If you want to add a meaning to the Par’s name, your answer should be Particular + Advanced + Rational, unique, difficult to meet, focus on high barriers first imitation products; technology leadership, ease of release, slow release multi-dosage formulations Proficient in everything; reasonable layout, wise and pragmatic, and strategic mergers and acquisitions blossomed.
The young Par used nearly 30 years of hard work to embark on a distinctive path and became another force behind the Big Three. The future is far away and the dream is very close.
Founded in 1978, Par was the sixth-largest generic pharmaceutical company in the United States before being acquired by Endo. It is headquartered in Woodcliff Lake, New Jersey, USA, and employs approximately 1600 employees to develop, produce, and sell generics and branded drugs. The company is divided into two modules, Par Pharmaceutical and Par Specialty, for the operation of generic drugs and branded drugs, and has several production bases and R&D centers in the United States and India.
Par is known for its high barriers to imitation products. Its business is mainly aimed at the US market and it has nearly one hundred products that are sold in the city. The products are mainly oral solid preparations, and they cover injections, inhalants and many other formulations.
In September 2015, Par was acquired by Endo and merged with Qualitest, a generic pharmaceutical company owned by Endo, to form the new Par Pharmaceutical, responsible for Endo’s generic business in the US market.
The newly formed Par Pharmaceutical headquarters is located in Chesnutryk, New York. The number of employees has increased to more than 3,700. It has become the fourth largest generic pharmaceutical company in the United States (according to 2015 IMS Midas data), with nearly 300 products for sale and about 120 products. The R&D product line made up of new products, along with more than 130 ANDAs being reviewed by the FDA.
When it was not acquired, Par’s total revenue in the first half of 2015 was US$691 million, an increase of 18% compared to the same period of the previous year, which was mainly due to the contribution of the growth of the generic pharmaceuticals (Par pharmaceutical) (+19.7%). (Par Specialty) accounted for only 4.3% (-5.6%). Qualitest’s revenue was US$695 million, an increase of 44% over the same period of the previous year, which was mainly due to the excellent performance of Lidocain (authorized generic drugs) and the incorporation of its share after DAVA’s acquisition.
At the end of September 2015, Endo completed the acquisition of Par. In the fourth quarter, Par and Qualitest merged to form the Endo US generics module (newly established Par Pharmaceutical) for a revenue report. This module generated a net revenue of US$1.672 billion for the entire year in 2015. Par contributed 383 million US dollars, an increase of 47% over the previous year.
As of the end of September 2016, the newly-consolidated Par’s total revenue was US$1.682 billion, an increase of 58% compared to the same period of last year. Revenues of the basic generic pharmaceutical business, aseptic injection business, newly-listed products and alternative dosage forms business were respectively It was 942 million U.S. dollars, 387 million U.S. dollars, and 354 million U.S. dollars, which was an increase of 32%, 5364%, and 3% respectively compared with the same period of last year.
The basic generic pharmaceutical business includes oral solid preparations (rapid release and sustained release), pain products and control products. The growth of this segment is mainly due to the addition of its oral solid product line after Par’s acquisition, especially a series of slow Controlled-release preparations, of course, the fierce competition in the market for solid oral preparations also played a certain offsetting effect on this growth.
The acquisition of injection products under the name of Par Sterial has played a decisive role in the growth of the sterile injectables business module, which has increased dramatically from less than 10 million before the merger last year to nearly 400 million today, including the NDA product Vasostrict® (plus Pressure injection is the most eye-catching, with the first nine months of sales reaching 249 million.
The new-market and alternative-dosage business modules include semi-solid suspensions, patches, oral solutions, sprays, eye drops, and other new formulations that have been marketed within the last two years. Dutasteride / tamsulosin capsules, pramipexole and diclofenac sodium gel (GSK licensed generics) marketed in 2016, Dallifera hydrobromide sustained-release tablets, Omeprazole bicarbonate Sodium capsules contribute a lot.
Product Overview and Strategy
a. Generic drugs
Unlike giants such as Sun, who are building generics and relying on product groups to increase their competitiveness, Par’s strategy for generic drugs does not specify key areas of development. Rather, it focuses on the development and introduction of high barriers, first filings, and the first listed products. As its core objective, it maximizes profits through high thresholds such as the production of difficult raw materials or preparations, complex patent litigation, etc. as much as possible to reduce competition, seek market exclusivity, or limit competitors to two or less to maximize profits. More than half of the profits of generic drugs in the year benefit from this strategy.
On this basis, Par is also actively seeking cooperation with brand drug companies to gain the opportunity for the introduction of authorized generic drugs, and further improve its competitiveness. Before the merger, it owned entecavir and many other giants such as BMS and Astra Zeneca. Authorized generic drugs.
After acquiring Boca and DAVA in succession in 2014, Qualitest’s generic pharmaceutical strength has been greatly enhanced. It ranks among the top 10 generic drugs in the United States. Its generic strategy is to improve the differentiation of generic drug product lines through the development of controlled products. At the same time, it will increase investment in R&D for products with low risk and high return opportunities.
As of the end of December 2015, Par’s sales of generic pharmaceutical products in the US market covered 95 chemical molecules and compound combinations, of which 89 were single dosage forms and the remaining 6 contained two dosage forms:
From the dosage form, there are 59 tablets (40 ordinary tablets, 13 sustained-release tablets, 5 orally disintegrating tablets, 1 lozenge), 20 capsules (6 sustained-release capsules), 12 injections, and suspensions 4, 4 nasal sprays, 1 gel preparation, surface solution, patch, eye drops, oral solid preparation accounted for nearly 80%, almost generic generic drugs, only a few brands such as Dynacin Generic drugs, in addition, include several authorized generic products such as budesonide capsules/sprays.
From the sales point of view, there are 5 molecules with 15 years of sales exceeding 100 million U.S. dollars, 37 molecules with 2015 sales between 10 million and 101 million U.S. dollars, and 33 molecules with 2015 sales of 1 million. – Between 10 million U.S. dollars.
As of the end of December 2015, Qualitest sold generic generic drugs in the United States market covering 136 chemical molecules and compound combinations, of which 110 were single dosage forms and the remaining 26 contained two or more dosage forms:
From the dosage form, there are 100 tablets (93 regular tablets, 4 sustained-release tablets, 3 chewable tablets), 16 oral liquids, 12 capsules (all are ordinary capsules), 12 syrups, and 8 suspensions. There were 5 creams, 3 ointments, 3 surface solutions, 2 ear drops, 1 patch, and 70% oral solid preparations.
From the sales point of view, there are 3 molecules 15 years of sales exceeded 100 million U.S. dollars, 31 molecules have 15 years of sales between 10 million and 110 million U.S. dollars, and 55 molecules have 15 years of sales of 1 million. Between 10 million US dollars. In addition to non-branded generics, Qualitest also owns more than ten brands of ANDA generics, of which contraceptives produced by Patheon of Canada account for the vast majority of them.
Par compared Qualitest products, there were a total of 17 molecules overlap, and further corresponding formulations were developed for further comparison, there are 6 molecules in the dosage form (red mark), the other 11 molecules in the two companies belong to different formulations.
Both Par and Qualitest are based on solid oral preparations, with injections and solutions as the second most advantageous point, as well as a small number of other dosage forms including patches, ointments, and sprays.
Qualitest is superior in oral solids, but Par is superior in slow-release formulations. Par’s orally-disintegrating tablets and Qualitest’s chewable tablets are filled with blanks; Par’s injections and other formulations and Qualitest’s Other formulations, such as solutions, provide good but seamless integration beyond the oral solid formulation, even if only one-third of the products that overlap in the molecule are in dosage form.
The impact of the merger is not great. Overall, after the merger of the two companies, the product line has been clearly complemented and strengthened. After the merger, the Par has been greatly improved in terms of the number of products and the richness of dosage forms, further increasing the market competitiveness. In terms of quantity, the total number of oral solid preparations that both parties have hit has exceeded 150, but the sales contribution of many of these products has been relatively limited. How to further optimize the oral solid product portfolio, better integrate and use related resources is also a pendulum. Problems that need to be dealt with immediately.
Before the merger of the two companies, the development strategy of their respective generic drugs is not the same, but it is not inconsistent. Both have played their respective advantages. The newly merged Par continued Par’s strategy of relying on high barriers to firstly emulate the idea, while also emphasizing the importance of different product groups formed by various alternative dosage forms. To a certain extent, it is well implemented. Previously the two sides complement each other’s generic medicine strategy and philosophy.
b. NDA brand drugs
Through the authorization of the introduction and the acquisition of JHP, Par formed the NDA brand drug product group focusing on injection products, which was previously operated through its subsidiary, Par Specialty. Qualitest is almost blank in this product area. After the merger, this part of the product is still produced and sold by Par, maintaining its stability.
Nearly 20 NDA products are already included in the generic pharmaceutical companies, including several new chemical entity NDAs, as well as new dosage forms, new prescriptions, and other 505(b)(2) NDAs in injections. In addition to tablets, suspensions, ear drops, capsules, and sprays of several other formulations, it is already abundant.
However, most products are old products approved before 2000. Although VASOSTRICT has such a rising star of the future, the overall profitability is relatively limited. There are only 3 products with annual sales above 10 million, and more than half of the products are sold annually. Less than 5 million.
Prior to the merger, sales of NDA branded drug modules accounted for less than 5% of Par’s total revenue, and will continue its previous state without new product supplements in the short term after the merger. In fact, this part can only be regarded as Par’s sideline, after Par’s strategy in the brand of drugs is mainly focused on the development of the first few profitable species while continuing to introduce new products through acquisitions.
After the merger, the positioning and functions of the Par were more clear. Prior to this, the “door-to-door communication” needs further in-depth transformation to “one-fine”. It is the top priority in the future to continuously improve its own generic pharmaceutical strength after completing the integration with Qualitest. As for making money from brand drugs, it’s still for Endo.
The combined Par has a total of seven major production sites worldwide, with six in the United States and one in India. Among them, the five bases in Chestnut Ridge, New York, Irvine, California, Rochester, Michigan, Stratford, Connecticut, and Chennai, India, originated from Par. Except for Base Camp New York, the other four are from the The acquisition of Anchen, JHP, Innoteq and Edict.
Sales of products manufactured at four bases before the United States combined accounted for 98% of Par’s annual self-produced product revenue, and only 2% for Indian bases; Charlotte, North Carolina and Huntsville, Alabama Bases are from Qualitest.
The layout of the two production bases before the merger should be said to be very reasonable. The production bases have clear division of labor and perform their duties. The production capacity is also sufficient to meet the production of their respective products. Except for some products that are subject to dosage forms and agreements, most Pharmaceuticals and branded medicines are very self-sufficient and well-to-do.
Before the merger, the number of Par’s self-produced products accounted for about 80%, and the remaining 20% of the products were produced by partners. In terms of APIs, Par’s main partners are all from India, including many well-known Indian pharmaceutical companies such as MSN, Aurobindo, Biocon, etc. Integration into Nuray Chemicals’ plant allows Par to possess the capability of producing APIs. More in the future The API will achieve internal supply.
After the merger, overlapping areas of the two large-head oral solid preparations appeared to overlap. Although the mutual influence of the products is not great, how to better integrate the production capacity according to the current actual production scale to further reduce the cost must also be considered. Some supporting measures such as selling plants and layoffs will follow.
In 2015, 6% of layoffs were first made. In May 2016, more than 700 people were laid off at Qualitest’s two bases. The latest development is the end of the year to 14 million for the whole Charlotte base that combines oral solids production, testing and product storage functions. The price of the US dollar was sold to Chinese brother Hua Hai in order to achieve the goal of saving 60 million US dollars in 2017.
Since the acquisition was completed at the end of September 2015, measures to reduce layoffs have already cost more than US$40 million. From the perspective of various bases, it is reasonable to consider that the relatively single-function Charlotte Base was abandoned, saying that Charlotte is Healing Qualitest as a minor, but unfortunately the fate of 24 years, or blessing the 38-year-old she can continue with the 27-year-old Huahai has been happy to go.
Lamotrigine sustained-release tablets, which Par and Huahai cooperated with, have maintained a sustained and stable growth since landing in the US market in 2013, with a sales share of approximately 31% in 2015, second only to original GSK, with a sales share of approximately 45%, ranking first. Huahai’s 2015 annual report shows Par as its fourth largest customer, with annual sales of 134 million yuan.
Through the aforementioned measures, Par’s post-merger production layout has become more streamlined while ensuring the production of existing products. The two solid dosage forms of tablets and capsules will continue to be the core of the future Par, Rochester, which is responsible for the production of injections. Other bases such as Huntsville, which is responsible for a series of liquid preparations such as oral liquids, will also play a more important role in the future. Reliance on self-sufficiency in self-sufficiency in self-sufficiency is still the trajectory of Par in the production field.
Research and development
Before Par acquired the R&D type generic company Kali in 2004, it had less than 50 R&D teams. The number of products under research and pending approval was less than 100, and the R&D capacity and scale were relatively limited. After completing the acquisition of Kali, Its research and development scale has doubled, and its research and development capabilities have been significantly enhanced. Kali had a product line for the development of oral preparations including several first-mentioned products, which was in line with Par’s high threshold strategy.
The subsequent acquisition of Anchen was even larger. It was a good player in the development of controlled release and patent challenges. It provided greater support for the improvement of Par’s R&D capabilities. Afterwards, several companies such as JHP and Edict acquired by Par had different characteristics. With both R&D and production capabilities, Par has also acquired matching R&D resources while harvesting products and plants, so it has acquired the present and future.
After continuous additions, Par has already had strong R&D capabilities before the merger. The number of products under development exceeds 100, and nearly 120 declared products are under FDA review. The R&D field is also the initial oral solid preparation. Based on injections, patches, sprays, films, etc., many other dosage forms have been expanded. More importantly, a relatively complete R&D system has been formed under the clear and clear product strategy guidelines.
Compared with Qualitest, Par has a higher level of investment in research and development and overall strength. After the merger, the new Par relies mainly on Par’s R&D resources before the merger. The current research and development base is mainly distributed in New Jersey. Lanbury, Chesternut, New York, Irvine, California, Rochester, Michigan, and Chennai, India.
The new Par will continue to emphasize the low-risk nature of R&D projects and the clarity of the drug control reporting strategy while continuing the merger and development strategy of the pre-merger Par high-profile product. In addition to its own R&D, Par will actively seek the introduction of excellent external products. After becoming Endo’s generics division, it is expected that future R&D investment will be further enhanced. By the end of 2015, the combined Par had over 120 ongoing products and 130 products under review.
Before the merger, in the first half of 2015, the total investment in Par R&D was US$55.425 million, which accounted for 8% of the total revenue in the first half of the year, a decrease of 12.1% compared to the same period of last year. Almost all of them were part of generic drugs; after the merger, Endo The annual research and development input of the US generic module was 58.418 million, mainly due to the fact that the incorporation of Par increased by 82% compared with the previous year.
As of the end of June 2015, there were 117 ANDAs in the FDA review stage before the end of the acquisition by Endo, of which 42 were the first to declare or had the potential for the first listing opportunity. After the merger with Qualitest, the two figures were updated to 130 and 38 by the end of 2015.
In terms of patent litigation, although Par has more gaps than several older brothers, Par also has a strong position and has acquired the strength to further strengthen its acquisition of Kali and Anchen. Statistics on the Newport database information are summarized. At present, the number of cumulative patent challenges and ANDA submissions under the Par name has exceeded 100.
From the perspective of the patented product formulations, oral solid preparations accounted for 72% of all products. Among all 78 products, there were 52 tablets and 26 capsules, of which 36 were slow-release products, accounting for nearly half of the total. Oral liquids and injections followed, accounting for approximately 10% of the total, and the remaining dosage forms had fewer products.
Judging from the number of competitors who have challenged the patent for the same product, 83% of products are between 0-9 and 56% of products are under 5. Of these, 13 are exclusive challenges, and the overall competition is moderate.
As of November 9, 2016, the FDA official website recorded a total of 47 first generic patent challenges and ANDA applications for generic products by the generic companies. Par had 4 exclusive claims in 41 of the identified challengers, only after Outstanding Teva.
In 2015, the company listed a total of 14 products in the US market, Par contributed 9 of them, Qualitest 5 (red), and all were generic drugs.
From the dosage form, there are 8 tablets, 3 injections, 2 capsules, and 1 surface solution; from the therapeutic perspective, it is relatively decentralized and there is no obvious advantage in the field; in terms of product production, Par’s products are all The production base is producing, and 4 of Qualitest’s five products are produced by partners such as Alembic and Patheon.
In terms of sales, the highest performing pramipexole sustained-release tablet has annual sales of approximately US$20 million, and guanfacine hydrochloride sustained-release tablets are also US$10 million or more. The remaining products range from tens of thousands to several million. . The number of products that were listed in 2015 had exceeded three million US dollars in the first half of 2016. Overall, Par’s products performed significantly better than Qualitest.
In 2016, the merged Par planned to list 21 products on the US market. From the perspective of the overall market size of the US products, three of them are worth more than US$1 billion, one product is between US$5-10 billion, and 10 products. Between 1-5 billion U.S. dollars. From the perspective of competition, nearly half of the product competitors are 3 or more; from the product type, 4 are sterile injections, and the rest are mostly solid oral preparations.
As of the end of September 2016, 15 products have been listed, and another 6 products are scheduled to be completed in the fourth quarter. Among them, quetiapine fumarate sustained-release tablets (first imitation, 180 days of exclusive period), and injection Mycophenolate (first imitation, the only injectable product in the city) and ezetimibe (first imitation, 180 days of exclusive period) three important products have been listed in the past two months.
M & A
Mergers and acquisitions are now commonplace in the US generic market. The big fish eats small fish and small fish eats shrimp. The outside buys the homeland as a stepping stone and stepping stone. The locals buy and expand and supplement the outside. They are surging and have never stopped. The influx of Chinese capital, which is not bad, further exacerbated the heat of the M&A market.
M&A is a means, a capability, and even a science. It is better to buy better than it has become the only way to achieve rapid expansion in the short term. Through a series of gradual mergers and acquisitions in the two major global regions of the United States and India during the decade, the Par, which occupies a geographical advantage, continues to accelerate on the way forward. Even if it does not move billions of major moves, it is stable and accurate at the same time. The practical shot is also enough to be called a classic.
Kali is based in Somerset, New Jersey, USA. It is a generic R&D company with production capabilities. Its products are sold primarily through partners. It was acquired by Par for $135 million in 2004.
At the time of the acquisition, Kali had 14 ANDAs in review status (of which 4 were the first declarations) and 12 product development R&D product lines. This acquisition has expanded Par’s product line. At the same time, the greater significance is to make Par’s R&D strength in the early stages of development have been greatly enhanced, laying a solid foundation for the subsequent launch of new products.
Anchen, located in Irvine, California, USA, is a company known for the development, production, and commercialization of controlled-release Liquibase generics products. It was acquired by Par for $410 million in 2011.
At the time of the acquisition, Anchen had 5 generic products sold in the city, 26 ANDAs in review status (of which 5 were the first to declare), 26 product R&D product lines and a total area of 72,000 square feet of factory facilities. . The acquisition of Anchen has greatly expanded Par’s original slow-release product line, and its corresponding R&D and production capabilities have been further enhanced.
Edict, located in Chennai, India, is a generic pharmaceutical company dedicated to the development and production of first-in-a-kind oral solid formulations. It was acquired by Par for $37.6 million in 2012 and was renamed Par Formulations after its acquisition.
At the time of the acquisition, Edict had 7 ANDAs under review, 14 product lines of R&D and supporting facilities. Through the acquisition of Edict, Par successfully expanded its global footprint to India, and its R&D and production capabilities in the area of oral solid preparations have been enhanced.
In September 2012, Par was acquired by US private equity firm TPG through its associated company, Sky Growth, for $1.9 billion. This acquisition enabled Par to receive better financial support in the future, and its financial position has been significantly improved. Due to the nature of the acquirer’s non-operating entity, except for the withdrawal of its original stock, the acquisition did not result in significant changes in Par’s operations, structure and related strategies.
Headquartered in New Jersey, USA, JHP is committed to R&D, production and sales of aseptic injection brand drugs and generic drugs, and also provides CMO services. It was acquired by Par in February 2014 and renamed Par Sterile after its acquisition.
At the time of the acquisition, JHP had 14 sales products in the city, 17 products under review, R&D product lines consisting of another 17 products, and a 171,000-square-foot factory facility in Rochester, Michigan. The acquisition enabled Par to enter the US injection market, with R&D and production capabilities covering anti-tumor and non-anti-neoplastic aseptic injections. At the same time, a series of branded drugs and generic drugs obtained greatly enriched Par’s original product line.
Innoteq is located in Strafford, Connecticut, USA, engaged in the development and production of innovative coated products, including transdermal patches, instant film, etc., and was acquired by Par for $26.4 million in January 2015. The acquisition expands Par’s original product type. The addition of two different dosage forms of patch and film well matches Par’s product strategy and further enhances Par’s market competitiveness.
- Ethics bio lab
Ethics bio lab is located in Chennai, India. It is a CRO company engaged in BA, BE and clinical trials. It was acquired by Par for US$10 million in January 2015 and was renamed Par Biosciences after its acquisition. Through this acquisition, Par has the ability to independently conduct BA, BE, and clinical trials, providing support for the conduct of various related research work such as BE required for the declaration of new products in the future.
- Nuray Chemicals
Nuray Chemicals is located in Chennai, India, and is dedicated to the R&D and production of APIs. Its FDA audited API factory and related assets were purchased by Par in June 2015 for US$ 19.3 million. Named Par Active Technologies, it is incorporated into Par Formulations. Through this acquisition, Par possesses the independent production capacity of raw material medicines, and at the same time, it provides strong backing for the future production of the preparations through the low cost of India.
In areas where there is no treatment area to be focused on, high barriers, first filing, and the introduction and introduction of the first listed products are its core objectives. The market seeks to reduce competition through high thresholds such as the production of difficult raw materials or preparations and complex patent litigation. Exclusive period or limit competitors within 2 to maximize profits
Emphasis on the development of alternative formulations in addition to a variety of oral solid dosage forms and the gradual formation of differentiated product groups
Increase investment in R&D for products with low risk and high return opportunities, pay attention to the clarity of the drug administration declaration strategy, and actively introduce acquisition of external excellent products through acquisition and authorization in addition to its own research and development.
Relying on its vast distribution network and strong sales capabilities, it has established a good partnership with major patent drug companies and strived to gain the opportunity to obtain authorized generic drugs.
Overall, the combination of Par and Qualitest has achieved a good complement of resources on both sides. After the merger, the newly formed Par has significantly increased the richness of its product line and its production capacity. As a generic module of Endo, its functional positioning is more definite, and the product strategies of the two companies have been continued. The funding and product support in the future will be even more forceful. With the incorporation of a series of new companies and several recent ones Following the listing of imitation products, Par’s performance in the future is worth looking forward to.
Difficulties and hopes coexist. Opportunities and challenges coexist. Par and Qualitest are companies that rely almost exclusively on the U.S. market. They do not have other regional points in the world as supplementary safeguards. As the competition in the US generics market intensifies, the combined Par is still facing a lot of pressure as it grows in size.
Both Par and Qualitest rely mainly on tablets and capsules as two major types of oral solid preparations, supplemented with liquid preparations such as injections and oral solutions. The field of oral solid preparations is currently the most competitive field, and the price war has intensified, even if it is Some barrier-free sustained-release preparations still have competition, and mitigation is only relatively speaking. While the Indian Army led by Sun has the advantages of local manufacturing cost, it has seen rapid growth in R&D and litigation in recent years. Par’s unique skills in housekeeping should be said to have certain advantages, but it is not enough to completely suppress competition from competitors.
From the other auxiliary fields, with the continued mergers and acquisitions of the generic drugs market, the field advantages of injections, dermatological preparations and other dosage forms are far less than those of the original, even if the elimination of injections such as Fresenius and Hospira specializes in injections. Compared with other companies such as Sun, Par’s product portfolio is also uncharacteristically advantageous, and some of the NDA injections obtained by the JHP acquisition have also been largely spent yesterday.
Personally think that the high barrier agent is a sword for Par, but the sharpness is not enough for the Swordsman. After some horizontal acquisitions and reinforcements through recent acquisitions, Par needs to penetrate vertically in the following days. Work harder and try to get bigger with the gap behind.
Segmentation As of the end of September 2016, Teva’s US market generated US$3.17 billion in generic drug revenue, and Mylan’s North American regional generics revenue was 3.03 billion. It is only that the generic pharmaceutical segment already exceeds the revenue of 1.682 billion yuan for all products under Par’s name, and Bo Zhongzhi’s Between the first three quarters of the United States, the total sales revenue of US preparations has reached 1.74 billion, and the group behind them is even more eye-catching. Who is No 4? let us wait and see.