Whenever it comes to India, some people say that it is an acronym for “I Never Do It Again.” Thick spicy curry flavors pervade the familiar haze and match with a variety of unique Indian flavors. “This is sour. It’s so cool that people can’t believe it.” It’s enough to once have been there in this life. Some people say that it’s a magical country. The Indian people who smiled and smiled are all in the heavens, omnipotent, climbing the train. There are all kinds of stunts, and the three subversions will surely allow you to rethink life. Others say that it is a living patriotism education base. After you experience it for yourself, you will know the prosperity and beauty of my great heaven and the moon will be your own home.
There are many slots, but the flaws are not good, India’s achievements in the pharmaceutical industry have been enough to make the whole world catch the eye, as the Indian leader to lead the Big Brother Sun led the younger brothers in the United States took a bloody road, proved with strength There is a bright Indian light over the flying stars and stripes.
Founded in 1983, Sun has a global headquarters in Mumbai, India. With more than 30,000 employees, Sun is the world’s fifth-largest generic drug company and India’s largest pharmaceutical company. The company’s business scope includes the R&D, production and sales of APIs, over-the-counter drugs and prescription drugs. It has more than 300 APIs and more than 2,000 products listed on the market, and its trade covers more than 150 countries around the world. The company has strong production and research and development capabilities. It has 15 R&D centers, 14 APIs production bases, and 33 formulation production bases worldwide. The products cover oral preparations, injections, topical drugs, inhalants, and ophthalmic drugs. Formulations and treatment areas such as cardiovascular, dermatology, neuropsychiatric, anti-tumor, anti-infection, digestive tract, respiratory tract, and diabetes.
Sun entered the US market in 1996 and its US headquarters is in Cranbury, New Jersey. Through a series of acquisitions over a period of 20 years, its strength in the field of generic drugs and over-the-counter drugs continues to increase. In 2015, it merged with Ranbaxy to become the number one Indian pharmaceutical company in the US market. Among the various therapeutic areas covered by the US market, its dermatology advantage is the most obvious. The sales of generic drugs and brand drugs in this field rank first and third in the United States, respectively.
At present, Sun’s business in the United States is mainly operated through its US subsidiary companies and its subsidiaries Ranbaxy, Taro, Caraco, DUSA, and Pharmalucence. Each company has a clear division of labor and closely cooperates with each other to jointly ensure Sun’s presence in the US market. The steady and rapid development.
In the fiscal year 2001-2016, Sun’s global net income increased year by year, from US$112 million in fiscal year 2001 to today’s US$4.24 billion, with a compound growth rate of 27%. In fiscal 2016, the company’s total revenue was 288.887 billion rupees (approximately US$4.24 billion), an increase of 3.4% over the previous year.
From the perspective of revenue composition, India’s domestic sales accounted for only 26% of sales revenue, the vast majority of revenue from overseas markets, of which the United States is Sun’s largest regional market in the world. In 2016 fiscal year, US market preparation income was 2.066 billion US dollars, occupying Of the total revenue, 48%, followed by emerging markets, Western Europe and other markets and APIs, which accounted for 13%, 8% and 5%, respectively.
In the ten years from fiscal year 2006-2016, the U.S. market revenue maintained an overall increase, with a compound growth rate of 38%. Ranbaxy’s business was included in Sun’s total revenue in FY2015, resulting in a significant increase in revenue in FY2015 compared with the previous year, an increase of nearly 40%. In the 2016 fiscal year, the U.S. market revenue decreased by 8% compared to the previous year, which was mainly due to the fact that the fierce competition in the generic drug market led to overall price declines. In addition, temporary restrictions on exports due to GMP issues at the Halol plant in India also affected the extent to a certain extent. American market income. Taro achieved a 10% performance increase in the fiscal year, imatinib generics first listed on the market in early 2016, all of which have buffered the decline in sales.
In the first half of FY2017 (as of September 30, 2016), Sun’s global revenue was US$2.357 billion, an increase of 13% compared to the same period of last year, of which US market preparation revenue was US$1.163 billion, an increase from the same period of last year. 17%, accounting for 49%, showed a good momentum, mainly due to the beginning of the 180-day exclusive period of imatinib, which led to the rapid growth of sales.
Product Overview and Strategy
I. Non-brand generic drugs
Sun’s U.S. non-brand generic products are sold under the names of Sun U.S. Companies and Taro, and a small number of products are sold by distributors such as Caraco. Most of the Taro products belong to the dermatology category. The basic products are different combinations of ointments, creams, gels, lotions, and surface solutions.
As of the end of June 2016, Taro’s products sold in the US market included 63 chemical molecules and compound combinations, of which 41 were single dosage forms and the remaining 22 contained more than two dosage forms, the most included ointments/creams/solutions/ A total of 5 gel/emulsion formulations; from the dosage form, 30 creams, 18 tablets (14 ordinary tablets, 2 sustained-release tablets, 2 chewable tablets), 12 ointments, 9 oral liquids, surface There are 8 solutions, 7 gels and emulsions, 4 capsules (1 sustained-release capsule), 1 nasal spray and ear drops. The total amount of sales in the first half of 2016 is US$10 million. There are 21 above-mentioned molecules, 49 over 5 million U.S. dollars, and 55 over 1 million U.S. dollars.
In addition to Taro products, as of the end of June 2016, Sun’s products sold in the United States covered 136 chemical molecules and compound combinations, the vast majority of which were single molecules, 19 contained more than two dosage forms, and most included 3 Formulations. In terms of dosage form, there are 102 tablets (83 common tablets, 15 sustained-release tablets, 3 orally-disintegrating tablets, 1 chewable tablets), 25 capsules (3 sustained-release capsules), 15 injections, and oral liquid 7 There were 3 eye drops, 2 nasal drops, 1 ointment and 1 lotion. From the sales point of view, there were 14 molecules with a total amount of over 10 million US dollars in the first half of 2016, 24 molecules with more than 5 million US dollars, and 56 molecules with more than 1 million US dollars.
Overall, the number of Sun’s non-branded generic products in the US market (according to dosage form statistics) has reached nearly 250. Tablets are the most important formulations, accounting for nearly half of all products, of which Taro products are mostly ointments. The comparatively modest formulations such as creams and creams complement the sun’s US market product line and improve its competitiveness. At the same time, its multiple molecules have been developed into more than two types of formulations. Its product strategy is more flexible.
Objectively speaking, although Sun’s product scale is still available and has strong support for the production of raw pharmaceuticals and preparations, the existing products, especially some of the lower threshold oral products, are mostly facing fierce competition in the generic market, such as IMA. After all, the number of heavy hitting counterfeit products is very limited, and once the end of the exclusive period, the price drop will be very large. In order to better cope with the market situation, Sun is currently developing high-tech thresholds for sophisticated generic drugs as a direction for future development, in order to rely on the development of the product itself to reduce the difficulty of competition, while relying on Taro’s R & D strength to further enrich and strengthen its skin The Division’s product lines, dermatology, anti-tumor and ophthalmology products are the focus of its efforts, and have made decisive cuts for some products with limited profits.
II. Brand drugs
Combining the FDA official website and IMS database, Sun’s current NDA branded drugs include 15 brands, mostly dermatological drugs, and are mainly based on ointments and creams, which are mainly sold by its subsidiary Ranbaxy. Other subsidiaries such as Taro are responsible for sales.
From 2015 sales, only one product of ABSORICA exceeded 100 million yuan. Only 5 products with more than 10 million products accounted for 10,000 to several million in sales of surplus products. From the time of approval, most products are Approved before 2000, fewer new drugs have been approved in recent years; from the type of application, 1 class of NDA applications for new molecular entities accounted for one-third of all products, and most of the remaining types are 505(b), such as changing dosage forms. (2) NDA applications.
On the whole, Sun’s NDA brand drugs are acceptable in quantity, but most of the products are already very old. After losing the protection of patents or data exclusivity, the profits from competition with generic drugs have been relatively limited. Although the ABSORICA at the top of the rankings is doing well, there is still a gap compared to the heavy town shop artifacts owned by other giants such as Copaxane and Epipen. Sun has also been striving to improve the NDA product line, and has actively expanded its NDA product line through its own R&D, acquisition or licensing, and joint development in a three-pronged approach. In recent years, it has achieved certain results, such as Insite. The acquisition of Vision and OST, and the development of its own Elepsia XR (Left-Belathiamine Sustained-Release Tablets) for US companies and joint development with ICGEB.
In addition to NDA brand drugs, Sun also owns nearly 10 ANDA brand generic drugs, mainly dermatology products, which are sold by its subsidiaries. Among them, PROCTOSOL-HC’s 2015 sales reached nearly 30 million. It is the best performing product among them, and the remaining products have sales of about a million. In addition, Sun is also actively seeking cooperation opportunities for certain brands of patented drugs to authorize generic drugs. At the end of October 2016, Sun’s series of Olmesartan medoxomil products, which were jointly developed by Sun and the first three, have been listed in the United States.
As a whole, India’s biosimilar level is still relatively limited compared to chemical generic drugs. Although the world’s first generic drugs such as Humira and many other heavy-duty monoclonal antibodies are all born in India, the quality of the products is still open to question. After all, in such an omnipotent kingdom of God, the barriers to entry and supervision are far from being comparable to that of Europe and the United States. The complexity, high input, and higher quality requirements of biosimilar drugs have determined that this is a different world from small molecular medicines. The achievements made by the Indian Legion in the field of chemical drugs cannot easily be replicated.
Sun acquired several eukaryotic expression biological products such as interferon alpha 2b, pegylated interferon alpha 2b, erythropoietin, and insulin, and infliximab bioimplemented with Epirus after integration with Ranbaxy. Entering the biopharmaceutical market, but objectively speaking, the strength is still relatively limited. On the way to Europe and the United States, Intas, Bicon, and other younger brothers have been left behind. Even sales in India have no advantage. The form is very serious, but what is valuable is that Sun has already begun the process of catching up with the full force, and its strategy is also very clear, that is, through the authorization to introduce at the end of R & D or R & D has been completed, the rapid development of new drugs and biosimilar drug products. It is believed that the cooperation between Sun and Merck on Tildrakizumab is just a beginning. There will be more follow-up actions.
The APIs account for only 5% of Sun’s annual sales, but it is of great strategic importance. The existing more than 300 kinds of APIs provide strong support for Sun’s formulation production, ensuring the low cost of the preparation, and it is still expanding at a rate of 20 kinds per year. Strengthening the research and development of complex APIs, and continuing to upgrade and maintain the long-term supply relationship with global API customers based on the current scale of production capacity together constitute the basic strategy for Sun Pharmaceuticals in the future.
Through continuous acquisitions, Sun’s global scale of production is also growing. At present, it has 14 raw material production bases and 33 preparations production bases in six continents. Nine of the 14 bulk drug production bases are located in India, two in Australia, one in the United States, Israel, and Hungary; 15 of the 33 manufacturing sites are located in India and four are distributed In the United States, there is one each in Brazil, Mexico, Canada, Hungary, Israel, Bangladesh, Ireland, South Africa, Malaysia, Romania, Morocco, Egypt, and Nigeria.
The global production base layout and the strong production capacity that covers a wide range of dosage forms ensure that it has ample supply of products for each market, while also reducing transportation costs. The vast majority of products in Sun’s U.S. market are manufactured and supplied by different subsidiaries located in multiple locations around the world. Most of the branded drugs, a small amount of generic drugs and APIs are produced by partners.
From the above table, it can be seen that Big Brother left the cooperation opportunity of APIs and generic drugs outside the field and all of them left to their own younger brothers, and the NDA brand drugs are mostly produced by US partners because of licensing agreements. In the list of younger brothers, Gland, familiar with the US market, has become familiar. On the scale of the round, Gland can only be regarded as the youngest brother of the Indian Bangli brothers. However, if he asks which injections are strong, it can be ranked top in the world.
In addition to its many injection products sold through its partners in the United States, Gland also received a large number of injection CMOs from the US market. Customers include Mylan, Sandoz, Sun, Apotex, top-level giants from all corners of the globe, and Perrigo. The likes of Xellia, and even more interesting are the injection masters Hospira and Fresenius, both of whom are also friends. It has been admirable that this injection can be produced to such an extent.
Personally think that Gland’s valuable point is to be able to do a solid, persevering intention to do a seemingly insignificant little thing, over time, keep improving, the small stream will gradually become a river. Finding a path that meets one’s own strength and can go one step at a time and proceed according to the objective law of the development of things, success will be a matter of course, and today only the first to imitate it, tomorrow will be a non-innovation enterprise, and the day after tomorrow will be a desperate company. Success can only be piously looking forward to fate.
Like many other Indian companies plagued by GMP problems, Sun, who is the big brother, is not immune. In 2010, it received the FDA warning letter for its Cranbury production base for the first time. In recent years Sun’s two manufacturing facilities in Vadodara and Halol in India received FDA warning letters in 2014 and 2015, respectively, which were sold in June this year. The Philadelphia factory at Frontida Biopharma also received an FDA warning letter in August.
Ranbaxy, who has suffered from the ravages of the mind, needs to say that the Taro Brampton and Caraco’s Michigan production bases have also been warned. In addition to production site inspection problems, there are also historical records of recalls of potential safety issues. It is not easy to fight the rivers and mountains, and it is not easy to defend the mountains and rivers. For Sun, how to manage a huge family business after the flies are getting full, and avoid the “chains of thousands of miles and collapsed in the burrows” chain reaction will become a major issue that needs urgent solution. In the face of defects and warnings, attitudes will become even more important.
Research and development
During the 2010-2016 fiscal year, Sun’s R&D investment increased year by year. The FY16 R&D investment was US$352 million, accounting for 8.3% of net income for the full year, an increase of 10% over the previous year.
Sun has 15 R&D centers and more than 2,000 R&D personnel worldwide. R&D centers are located in India (10), United States (1, Cranbury), Canada (1, Bington), Israel (1, Haifa), Romania (1, Cluj) and Ma Lathia (one, Sungai Petani).
Sun’s R&D is jointly developed with APIs and preparations. The R&D of R&D is divided into two parts: innovative drugs and generic drugs. It covers a wide range of dosage forms such as oral, injection, inhalation, and topical drug use as well as multiple therapeutic areas. The platform has laid a solid foundation for the continuous launch of new products. Through the successive acquisitions and mergers of companies such as Taro, its R&D strength has been further enhanced. At the same time, Sun also has the right to develop and administer controlled pharmaceutical raw materials and preparations.
In terms of innovative drugs, research and development are currently conducted through its Sun pharma advanced research company ltd (SPARC), which was established in 2007. It is divided into two major R&D modules: NCE and NDDS. The NCE module is mainly for the development and research of new chemical entities in the field of anti-tumor and soft-hormonal anti-inflammatory products. The NDDS module is mainly aimed at existing chemical molecules. It can be controlled release system through gastric retention, controlled release system by matrix, and can be degraded. Technical platforms such as biological implants, nanoparticles, expanded micelles, and dry powder inhalation upgrade existing formulations.
In the area of generic drugs, oral solid preparations, especially tablets, are the main areas of research and development. After the acquisition of Ranbaxy, the strength of the sector has been further enhanced. The incorporation of Taro is a good complement to its research and development strength in dermatology and generic drugs. , creams, gels, lotions, and other types of dermatology used to enrich the types of formulations to improve product differentiation. In recent years, Sun has strengthened the research and development of complex generic drugs. On the existing basis, Sun has further enriched its product line and enhanced its competitiveness by enhancing the development of differentiated formulations such as injections, inhalants, and ophthalmic drugs.
In addition to its own R&D, Sun is also actively conducting joint development through cooperation in order to complement each other, further improve R&D efficiency, and further broaden its R&D field.
In FY 2016, Sun submitted 22 ANDAs, 14 of which were approved by ANDA. A total of 20 DMF filings were submitted and 10 were approved. As of the end of September 2016, Sun’s total number of ANDA submissions has reached 567 (Sun’s sale of Bryan to Nostrum has caused a cumulative decline in fiscal year 16), of which 423 have been approved and the cumulative number of DMF applications has reached 434, of which 305 Has been approved.
The approved 423 ANDA were distributed in multiple therapeutic areas, including 102 and 101 central nervous system and dermatology respectively, with two strong rankings, with obvious advantages, followed by cardiovascular, pain, anti-allergic, and anti-inflammation. Cancer, metabolism, anti-infection, gastrointestinal system and other types.
Sun’s cumulative ANDA breakdown by treatment area (as of F1 2017)
In terms of patent litigation, the strength of India, led by Sun, has continued to increase in recent years, leading the US market to spur a wave of Indian whirlwinds that “do not speak for a challenge”. Statistics of Newport database information is summarized. At present, the number of accumulated patent challenges and ANDA submissions under Sun’s name has reached 154, of which there are 86 under Sun’s US company name (15 overlap with other subsidiaries such as Ranbaxy and Taro). Ranbaxy’s name is not There are a total of 31 overlaps, 20 of which do not overlap in Taro’s name, and the rest are under Caroco and Mutual.
From the patented challenge product formulation, tablets accounted for nearly 60% of all products, followed by capsules and injections; from the number of competitors for patent challenges on the same product, 75% of products were between 0-9,37 % of the products are under 5, and the overall competition is moderate. Among them, the dermatology products under the Taro name are less competitive, with more than 5 competitors.
In the first half of 2015-2016, Sun listed 24 products in the US market, and Taro contributed 8 of them, all of which were dermatological products.
From the dosage form, there are 13 tablets, 4 creams, 2 injections, and capsules, oral liquids and other types;
From the perspective of the treatment field, it is relatively scattered and distributed in areas such as anti-infection, cardiovascular, psychiatric, and anti-tumor, and there is no obvious advantage;
From the point of view of sales, imatinib tablets took the lead. As the first product to be copied, 200 million copies of the transcripts were surrendered in the first half of 2016. The tetrabenazine tablet was the second, except for imatinib. Tens of millions of products, the remaining product sales ranging from tens of thousands to millions. The vast majority of products launched in 2015 maintained a growth trend in 2016. In 2016, half-year sales have already approached or surpassed 2015 annual sales, but some products are not ideal, such as injection of carboplatin. In the first half of 2016, Liquid sold only more than 200 pieces and sold less than US$5,000.
In early 2016, Sun made a decision to stop the commercial sale of the new drug Keveyis (dichlorosulfone tablets) for the periodic paralysis marketed in 2015.
Sun’s TOP10 product contains five molecules containing more than two dosage forms, all from Taro. From the treatment perspective, dermatological products accounted for four, the remaining six were distributed in the cardiovascular, spiritual, anti-tumor and other fields; from the dosage form, ointment and cream two dermatology basic dosage form accounted for the largest proportion, followed by capsules and Tablets, only one injection of doxorubicin hydrochloride, include both common injections and liposomal injections. Due to the lack of product liposome injections in the US market, Sun’s ANDA first appeared on the market after being approved for accelerated approval, becoming the only approved generic drug product for doxorubicin liposomal injection in the US market.
In terms of sales, the only NDA branded isotretinoin capsules ranked top in the TOP10 products, and the remaining nine were both ANDA generic pharmaceutical products. Among them, sales of three products also exceeded 100 million. Sales of the remaining six products range from 60 to 100 million U.S. dollars;
In terms of rankings, six products were ranked top 10 in the previous year, and valsartan tablets, duloxetine capsules, doxycycline tablets/capsules, done cream/ ointment/emulsion in 2014 Top 10 A total of 4 products fell out of the top 10 in 2015, mainly due to the fact that fierce competition in generic drugs continued to lower the overall price of the market, which in turn dragged down sales. Among them, the valsartan tablet received a 180-day imitation exclusive period. Impact after expiration. When the overall market price continues to fall sharply, the significance of the share becomes smaller and smaller. Shares and prices are the two basic points that directly determine whether to make money or not. Sometimes it is very harmonious and sometimes contradictory. Efforts, but the extent of hard work can not keep up with the changes in this world.
Sun’s 20-year history of development in the US market is also a history of surging acquisitions. It has a dual-pronged approach in branded drugs and generics. Through a series of strategic mergers and acquisitions targeting different types of companies, M&A targets Ranbaxy, which was once the eye-catcher of the past. The king, as well as Taro field specializing in surgery industry, as well as bright future stars such as InSite Vision. Through the acquisition of its product line, R&D and production capabilities, it has been rapidly strengthened, and it has continued to grow after entering the US market and quickly gaining a foothold.
In November 2015, Sun completed the acquisition of InSite Vision, an ophthalmic brand drug company, and obtained two commercial products, several end-of-clinic ophthalmologic brand drugs and ophthalmic brand drug development platforms, which have further enriched the company. Brand drug product line.
Through its own strong patent litigation ability, it challenges patents for high-margin products, thereby gaining the opportunity for generic generics to be listed to maximize the benefits.
Through its R&D platform covering multiple technologies, it accelerates the development of barrier-free high threshold products, increases its degree of differentiation, and maximally avoids fierce market competition.
Through active joint development, authorized introductions and strategic acquisitions, we will continue to enrich specialty brand drug product lines with higher added value, reinforce critical gaps, and create more advantageous areas and new business growth points.
Through the rationalization of the global scope and strong production capacity, we have minimized input costs, increased continuous investment in key products such as differentiated products, and increased the contribution rate of brand drugs and complex products.
As a leader in the Indian market, the Sun’s overall strength in R&D, production, and patent litigation is unquestionable. In recent years, Sun has achieved high-speed development through its development strategy combined with strategic M&A, but objectively There is still a big gap between the Big Three and the previous three giants. The back of the elder brother Teva has gradually become obscure. The second brother, Sandoz, is bound to become more and more distant in the future when he enters the younger brother, Amneal, and is unwilling to be lonely. Even if it is temporarily quiet, there will be great action in the near future.
For Sun, the goal of catching up with big brothers in the short term is unrealistic. The most important thing to do now is to solve the problem of quality problems and move forward step by step according to the existing strategy. Internally strengthen the development of complex generic drugs and innovative drugs. The introduction and joint development of externally-developed brand drugs will be complemented by targeted targeted and targeted acquisitions, and will create more business growth points through a multi-pronged approach in order to achieve stable profitability and growth.
In the US generic market, India is a sign, a history, and even a force. It is believed that the talented Indian legions will create one magic after another in the future. Sun, who is the king of the banner, will surely Let the brighter light shine on this beautiful day without falling on the earth.