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There is no big brother’s hundred years, no family property, no second brother’s strong background, unique skill, the young three brothers inherit the spirit of the beginning of the old soldier, the firm belief of shining the United States, on the way to the success of the home road. Although today is a dress in the body, but the bone has long been engraved with the branding of the stars; though the road is long and the thorns are dense, the beautiful dream in the heart has never changed. There is a will, and it is true that the brave Mylan will write a more glorious legend with his hand, and let us witness the brighter light of the bright star over the United States.

Company Profile

Mylan was established in 1961. At present, the registered office of the company is Amsterdam, The Netherlands, and its global headquarters is located in Canonsburg, Pennsylvania, USA. With more than 35,000 employees worldwide, Mylan is the third largest generic pharmaceutical company in the world and in the United States. The company is divided into two major departments: generic drugs and specialist medicines. It has 12 R&D bases, 9 API production bases and 35 formulation production bases worldwide. The business scope includes R&D, production and sales of APIs, generic drugs, and some patented drugs. There are more than 250 APIs and more than 1,400 formulations listed on the market. The trade covers 165 countries around the world. .

Mylan has strong strength in R&D and production. The existing product lines cover oral solid preparations, injections, patches, inhalants, ointments and other dosage forms. The annual production capacity of the main products is: 65 billion tablets/grain oral solid preparation, 3600 kiloliters of APIs, 500 million injections and 260 million patches.

Sales performance

Before entering the topic, first join us in the concept of “Tax Inversion.” In simple terms, it refers to the way in which companies change their place of registration (such as moving from a high-tax rate country to a low-tax rate country) in order to pay less tax, change the higher tax rate of the country where it was originally applied to the tax rate of the newly registered country. . Mylan registered the integrated company in Amsterdam during the acquisition of the Abbott generics business in 2014. It transformed itself into a Dutch company with a tax rate of 20% or less. The company’s bosses ran to the UK office.

Actually, Mylan used an innovative tax inversion model that was different from the traditional one in this transformation. The first acquired Abbott was not an overseas company, and the second acquisition entity was only part of the company’s business. As the US government has gradually strengthened With restrictions and controls, the difficulty of such operations in the future will gradually increase.

Although the registration has changed, Mylan is still a US company that has taken root from the ground. Mylan’s total revenue in 2015 was US$9.43 billion, an increase of 22.1% compared to the previous year. Total profit was US$4.22 billion, an increase of 19.5% from the previous year, and a profit margin of 44.7%. The annual revenue of generic drugs was US$8.205 billion, an increase of 25.9% over the previous year, of which North American revenue was US$3.9 billion, an increase of 16% over the same period of last year, accounting for 47.8% of the total revenue of generic drugs; the annual revenue of specialty drugs It was US$1.242 billion, an increase of 1.92% over the previous year.

As the competition in generic drugs is further intensified, many of Mylan’s products are under tremendous pressure to reduce prices. In 2015, the overall sales revenue of the original generic pharmaceutical products in the world’s largest US market declined, but they depended on Epipen and other branded products. As well as the good performance of the newly-listed products, the overall sales still achieved significant growth.

IMS data shows that Mylan’s US market sales revenue in 2015 increased by 8.9% compared to the previous year. Sales of Epipen exceeded 1.6 billion, continuing the good momentum of the previous race, and contributing the largest growth point; sales of new esomeprazole magnesium enteric-coated capsules exceeded 100 million in the first year, together with other new The listed products contribute another growth point.

In the first half of 2016, Mylan’s total revenue was US$4.75 billion, an increase of 12% over the same period of the previous year; total profit was US$2.08 billion and profit margin was 43.7%. The total revenue of generic drugs was US$4.07 billion, an increase of 9.8% compared to the same period of last year, of which North American revenue was US$1.93 billion (from 2016, the Brazilian market revenue was allocated to North America from the rest of the region, which accounted for about 0.21 billion USD), which represents a growth of 7% compared to the same period of last year, and accounted for 47.2% of the total revenue of generic drugs; the total revenue of specialty medicines was US$ 674 million, an increase of 27.4% compared to the same period of last year.

Product Overview and Strategy

Mylan currently has 12 R&D centers worldwide, including 3 in the United States. The most famous is the Morgan City Base in West Virginia, which is responsible for the R&D and production of its oral solid preparations, and the other 9 R&D sites. Located in the United Kingdom, Ireland, Canada and India. In addition to its own research and development, Mylan is also actively expanding its existing US market for generic drugs and specialty pharmaceutical production lines through cooperative R&D and product licensing. In addition to small-molecule chemical drugs, Mylan also actively explored the biosimilar field and achieved some encouraging results.

The R&D expenditure in 2015 was US$672 million, an increase of 15.5% over the previous year. In the first half of 2016, the R&D expenditure was US$433 million, an increase of 28% over the same period of the previous year. From the ever-increasing investment in R&D, it can be seen that the intensity of its product development and introduction has been continuously increasing, and the growth has mainly come from Mylan’s further investment in respiratory systems and biological products.

Generic drugs

As of the end of 2015, Mylan has more than 430 generic drugs on sale in the US market. Its product treatment areas are mainly anti-tumor, pain, anti-infection and cardiovascular, and dosage forms are mainly oral tablets, injections, patches, creams, and condensates. Gel, one of every 13 prescriptions on the US market comes from Mylan. Of all generic products, about 330 are capsules and oral tablets, and the number exceeds 950; there are about 50 slow-release products in all products, with about 125 specifications. In addition to oral agents, injections are also one of its important formulations. They have more than 70 injection products with about 90 specifications, and about 108 other injection products are in the ANDA review process.

Tablets are Mylan’s main product formulations, and account for the largest proportion of all products. Mylan’s existing tablet product line also covers all important tablet generics on the US market. Although the scale is large, the competitions faced in recent years are fierce. More generic rivals even seize the market at a price lower than the cost, even if they have a significant impact on products that Mylan has a clear share of. With great pressure to cut prices.

In order to better cope with competition, Mylan has strengthened the research and development of high-barrier hard-to-improve products covering a variety of dosage forms, strived to expand its existing product lines, and at the same time relied on strong drug certification and litigation strength to actively carry out patents. The challenge will be to win the opportunity for first-to-market or early-morning markets. In its main field of oral solid preparations, several slow and controlled release products have been launched in succession in recent years, many of which are listed as generics and have laid a larger share in the early days.

In 2015, FDA’s official website recorded a total of 58 first-patent challenge ANDA applications for generic products by patent companies. Mylan took up 11 of them, including 4 exclusive first reports and 7 shares with other generic drug companies. The first report, the overall performance is second only to the powerful Teva.

Branded drug

According to the statistics of IMS database and FDA official website information, as of the first half of 2016, Mylan sold a total of 16 NDA brand drugs, covering injections, inhalants, oral agents, creams and patches, of which injections accounted for 6 of them. Is the largest dosage form.

From the sales point of view, there are 3 products with sales of more than 100 million US dollars, while the sales of 4 other products are between 10 million and 55 million, and the remaining products are below 10 million. Therefore, not all brand drugs of Mylan can make a big deal, especially the profit of some products that have passed the patent period is very limited. From the ranking of these products in Mylan’s nearly 400 molecular sales, we can see that Mylan can really rely on just a few of them. It would be only TOP3 to make a great contribution.

Among all 16 products, Epipen, who was ranked first on the list, dominated the market for many years. It is the only product that has sold more than one billion yuan. It is a well-known town shop artifact of Mylan.

Epipen is an adrenaline automatic injection pen for the treatment of acute allergies. The NDA of this product was approved by the FDA in 1987 and is considered to be a long-established old drug. It was originally owned by Der Pharma, a subsidiary of Merck, and the company was in 2007. It was acquired by Mylan and was renamed to Mylan Specialty today.

Currently, the Epipen marketed in the United States has two types, yellow and green, with specifications of 0.3 mg/0.3 ml and 0.15 mg/0.3 ml, respectively. In addition to the two injection pens containing medicines, there is a “training pen” without medicines in the intimate packaging for practice before formal use. At the critical moment of the onset of an allergic reaction, the thighs can be taken off immediately, making it an indispensable first choice drug for allergies at home. “Short term validity + good efficacy + self-help convenience + wide range of applications” has enabled the product to keep rising in sales in the last ten years. In 2015, the total sales volume of all specifications in the United States has reached 7.837 million, similarly “loose” “Competitive + constant price hikes” has brought huge profits to Mylan while the volume has increased. The sales volume has been increasing in a straight line. In 2015, US sales exceeded 1.6 billion.

Previously, Epipen, with its splendid scenery, has recently gotten a share of the matter. “The price storm” and the “confidence crisis” have caused Mylan to be criticized. The days are not really good enough. The “price increase storm” said that this artifact costing less than $20 has skyrocketed from $100 to $600+ in nearly a decade, causing widespread dissatisfaction among consumers and government officials.

The turmoil intensified and Mylan began public relations under the crisis. First of all, a paper was published on the official website, which detailed the efforts made by the company in recent years in pursuing the health of allergy sufferers, including the “Epipen concession card” and “Epipen free admission to the campus”. In summary, it is to tell everyone that Mylan is actually The health of the people has always been placed first, and how much money is earned is not an issue. The second step is to give everyone some practical ideas. Three days later, words such as “strengthen further” and “swiftly take measures” appeared in another article on Mylan’s official website. At the same time, “$300 discount card” was released. Somewhat surprisingly, Mylan resorted to the third move four days later and decided to introduce the two generic Epipen authorized generics at a price of US$300 in the near future. The product itself will be exactly the same as the branded drug, and the follow-up will continue. Take some measures to further save money for everyone. After the three strokes, the entire world seems to be a little calmer, but the voice of opposition is still continuing. After all, this price is still too expensive for many people.

Either way, at least Mylan is already working in the right direction. In fact, the frequency of Mylan’s price increase is indeed a bit of a dilemma, but the circulation of pharmaceutical products also makes the price a lot higher. In addition, there are two points to explain: 1. 600 US dollars is the price of a package of two products, not After hitting a pin, the 600 knives were dropped; 2. Some people said that Mylan intentionally made the package into two sales. In 2010, the FDA suggested that patients should have at least two at the same time, so that the first one does not matter, so Mylan began to gradually withdraw the single installment, and began to push the two outfits. So price increases are the root cause.

As the saying goes, the government is not alone. The government pointed out that Myland did not properly classify EpiPen in the Medicaid introduced by the government. Epipen, which should be used as a patent brand drug, was classified according to generic drugs, which would have been according to 23 % of the percentage of expenditure rebates to 13% of the implementation, thereby saving the large amount of money should not be saved, so Mylan fell into a crisis of confidence. This time it was wrong and there was no better solution. So the problem caused by the money was to let the money to solve it, and ended up with Mylan agreeing to pay 465 million U.S. dollars.

If you arrange the story of Mylan and Epipen into a TV series, you may call it “walking on the tip.” At the time, Epipen could “hold it in the end and be invincible.” Mylan can proudly say, “If I say faster than others, it is because I stand on Epipen’s shoulder.” But when it’s not right, Epipen can also let Mylan “knit up and stumble,” and it really makes him happy to worry about it.

After reading Epipen’s story, you can appreciate the importance of this product for Mylan. At present, Mylan’s strategy on branded patents is also very clear. It is to further strengthen the Epipen. In the case of limited price increase strategy, it can be used to make up for the increase in the quantity, while strengthening the current respiratory and dermatology departments with certain advantages. Patent protection product development and introduction in each field, aiming to form a group advantage in the therapeutic field with existing brand drugs and generic pharmaceutical products at the same time as individual product profit, and further enlarge and enlarge several key areas with current sales of over one billion yuan. Create more business growth points beyond Epipen.

Biosimilars

In terms of biosimilars, Mylan currently conducts research and development of generic drugs through its own R&D and third-party cooperation models. Earlier, Biocon had 6 biosimilars (trastuzumab, long-acting filgrastim, non-lattice). Siting, Adalimumab, Bevacizumab, and Etanercept) and 3 Insulin Products (Insulin Glargine, Lisprosin Insulin, and Aspart Insulin) Cooperate at the R&D and Production Levels, Starting in the Early 2016 with the United States Momenta collaborates on R&D in 6 additional biosimilars (according to people speculating on rituximab, abatacept, denosumab, panitumumab, omalizumab, and alemtuzumab) According to the agreement, Myland will pay Momenta’s advance payment of US$4 million, assume 50% R&D costs and promise to pay more than US$200 million in mileage. In addition, the two companies will also share profits.

Objectively speaking, Mylan still has a certain gap between bio-pharmaceuticals and Teva and Sandoz. The elder brother, who had always been the leading force, continued to make efforts to promote the product in the United States market. The older brother who started earlier has recently teamed up with South Korea’s Otsuka Celltrion to continue to increase the code. Looking at the back of the two older brothers, the younger brother of Mengmeng is really worried about the baby. He still has to redouble his efforts in the future.

API

After the acquisition of India Matrix, Mylan’s raw material drug strength has been greatly enhanced. It has provided stable support to Mylan’s worldwide production of pharmaceuticals while profiting external sales, greatly reducing the supply of APIs. A problem that affects the risk of the production of the formulation has been internally controlled, at least to a certain extent. At present, Mylan distributes 9 pharmaceutical raw material production bases in India. There are more than 250 kinds of API products with an annual production capacity of 3,600 kiloliters. At present, the pharmaceutical raw materials for various preparations of Mylan’s US market are provided by its Indian factories, and at the same time, it has also established a cooperation relationship with some other companies in the world.

Drug Listing and Registration Profile

In 2015, Mylan submitted a total of 1,049 product listing applications worldwide, including 41 in North America, 522 in EMEA, and 486 in the rest. In 2015, Mylan applied for 731 product listing applications worldwide, including 77 in North America (56 in the United States), 396 in Europe, and 258 in the rest. Of these, 44 were anti-retroviral drug applications and distributed on 14 products in 13 countries; of the 56 U.S. approvals, 45 were final approvals and 11 were provisional approvals. As of the end of 2015, Mylan had 4,109 product listing applications pending approval in the world. In the United States, there are 270 pending ANDA, of which 50 are ANDAs that contain the Paragraph IV challenge patent.

Mylan went public in 2015

In 2015, Mylan listed 26 products in the US market, all of which are generic drugs. They cover four dosage forms of tablets, injections, patches and capsules, of which 19 are tablets, 3 are injections, 2 are patches, and 2 are capsules. Species. It can be seen that the advantages of the tablets are not obvious, and 19 types of tablets include disintegrating tablets, sublingual tablets, sustained-release tablets and ordinary tablets.

It should be pointed out that these 26 products are not all Mylan’s new products (Molecule Corresponds Formulations have not been marketed previously), some of which are further supplements to existing specifications, such as fentanyl transdermal patch, is in the original Some of the five specifications are based on the new 37.5, 62.5, and 87.5 μg/h three specification products; some products are based on the previous release of controlled release upgrades, such as glipizide sustained-release tablets and fluoride Statin sodium sustained release tablets, previously common tablet products have been sold in the city; some products are based on previous specifications have been adjusted on the basis of packaging, such as levonorgestrel acetate ethinyl alcohol tablets had previously 0.15 The mg/0.03 mg specification is sold in the city for 28 units. This time, the 28-piece single board is adjusted to 91 units without changing the specifications.

From the perspective of indications, products cover several therapeutic areas including cardiovascular, analgesic, hormonal, and anti-infective areas. There are no particularly prominent areas in terms of quantity. The number of products in the above four major areas is basically the same. Flat, anti-tumor, anti-viral and psychotropic fields all contributed to some products. From the point of view of sales, the imitation products are both large drugs with an annual sales of several billion US dollars and some tens of millions of products. The smallest size of the Nevirapine sustained release tablets is listed in the previous 12 Sales of only 68,000 US dollars. The best performance of Mylan products after market launch was esomeprazole magnesium sustained-release capsules. In the first half of 2016, sales exceeded 100 million, and several products such as bexarotene capsules also exceeded 10 million. The overall performance is still high. Yes, the three products that are marked yellow have obtained 180 days of exclusive period, and they are the first listed products.

As of October 23, in 2016, Mylan launched a total of 20 products on the US market, all of which are generic drugs. They cover four dosage forms of tablets, capsules, injections, and oral liquids, including 13 tablets, 4 capsules, and injections. Two kinds of oral liquids, the advantage of the tablet is still not long obvious, in the 17 kinds of oral solid preparations, including 5 kinds of sustained-release products. The three products, including the yellowed modafinil, received a 180-day exclusive period, allowing it to be listed first. The rosuvastatin calcium tablets in the imitation products are one billion products, and the rest of the products are also more than US$20 million in data before the listing in December. In terms of treatment, the cardiovascular category accounted for the largest proportion and the anti-infective category followed.

TOP10 products

Seven of the Mylan TOP10 products are generic drugs, and Epipen and others are NDA brand drugs. From the sales point of view, Epipen riddled with fierce competition, followed by L-Hydroxygenin tablets, and its sales exceeded 500 million U.S. dollars. The remaining 8 products have little difference, and they are all over 100 million U.S. dollars.

In terms of dosage forms, there are three tablets, two capsules and two patches, one each for gels, injections, and inhalants; in terms of indications, the distribution is very fragmented and there is no exactly the same therapeutic field; from the perspective of ranking, The rankings of the three players did not change from last year. The four products in the 4, 5, 6, and 8 positions have changed slightly compared to last year. Norogestrel/ethinyl estradiol and capecitabine tablets This product has undergone major changes and reached the top 10 of the year with a low ranking last year. The biggest surprise came from the esomeprazole magnesium sustained-release capsule, which was ranked tenth place, and was obtained in the first year of its listing. Break through 10 billion successes.

Compared to the Top10 product list in 2014, sales of atorvastatin calcium tablets, fenofibrate tablets/capsules, metoprolol tablets, and omeprazole enteric capsules all took a different degree The slide fell out of the top ten. The first three products fell to 13, 14 and 24 respectively in the 2015 list, and it is still more or less plausible that the worst omeprazole enteric capsules slipped to the end and fell to 127. Actually, in terms of the product, Mylan’s performance before 2014 was always a smash. Until 2014, sales were caught by Sandoz, but after all, it was a second place. In 2015, it was directly reduced from 100 million to 100%. Million products. Just as everyone is embarrassing, Mylan’s new generation product, esomeprazole magnesium, is quietly rising. Maybe Mylan is playing a big game in the next round.

Acquisition

In today’s global market environment, it is very difficult to emancipate the mind to take advantage of the brain. It is very difficult for us to go further. Therefore, through acquisitions and cooperation in various fields, it will be a common practice to become bigger and stronger. This is particularly true of the ambitious local tyrant Mylan.

In terms of acquisitions, Mylan has continued to move in recent years and has enriched its existing product line through a series of targeted acquisitions, further enhancing its strength in areas such as dermatology, and has been well compensated in the fields of generic drugs and branded patent drugs.

Of course, the most exciting ones are the two terrific acquisitions between Teva, Mylan and Perrigo. Mylan is decorated in two corners, and two channels are broadcast simultaneously. The plots are similar to each other and can be called the annual huge contribution in the American generics circle.

In fact, the original protagonists were only Mylan and Perrigo. After Mylan made an offer to Perrigo at the beginning of April, he did not expect Teva to enter the mess and sent an offer to Mylan at the end of April. So Mylan chased Perrigo eagerly and relentlessly, and on the other side, he also insisted on Teva. “The concept is fundamentally in conflict”, “Seriously underestimating the value of Mylan”, “There is no reason to sell the company on the road to success.” Mylan’s management has a clear-cut view, but some shareholders are still impressed by Teva’s offer, which occupies Mylan 14.5 at the crucial moment. Abbot, the largest shareholder of the shares, came out to support the management’s decision. Mylan finally succeeded in holding on to independent positions.

In July 2015, Teva announced an agreement with Allergan to give up the acquisition of Mylan. Mylan sent a blessing for the first time, indicating that in the future Mylan will continue to implement its own strategy. At this time, Mylan could finally concentrate on continuing Perrigo’s offensive.

Like Mylan, Perrigo has a clear-cut attitude from beginning to end, that is, he would rather die and resolutely fail to show off the spirit of bold bravery. From April to 11 in the tug of war, the company has been relentlessly mobilizing shareholders to boycott acquisitions. “Do not let Mylan’s contributions succeed.” from Perrigo’s official website is a good summary of its constant voice in this process. In the end, this drama ended with Mylan’s departure.

Teva, who had come for Mylan, eventually succeeded with Actavis. Mylan and Perrigo, although they did not succeed, had at least successfully rejected what they did not like. When the music “It’s a pity that doesn’t you” sounds, it may be a win-and-win outcome that is both happy and not lost.

Cooperation

Like Sandoz, Mylan is also a company that is inextricably linked to India. Apart from its own 24 production sites for raw materials and preparations in India, Mylan also works with a number of Indian pharmaceutical companies such as Gland and MSN. The company has cooperated with the production of pharmaceutical products in the US market and the supply of APIs. At the same time, Mylan U.S. companies are also mostly active Indian-speaking leaders and employees. Their current president, Rajiv Malik, is also Indian. He is the person who will add a few words after the beauty CEO’s speech on the product launch or cooperation. This monarch made his debut in Ranbaxy. Before entering Mylan, he was the CEO of Matrix. After Mylan acquired Matrix in 2007, he entered Mylan management.

List of Mylan India production sites

 

Like other multinational corporations, Mylan’s three factories in India also received FDA warning letters in August 2015. They are also facing a lot of pressure, so they can play in the magical country of India. It is the real life winner.

In addition to its partners in India, Mylan also cooperated with a number of companies in Europe in the US market to develop product preparation and raw material supply, and its current cooperation with Chinese companies is limited to the raw material field.

Mylan and US-based companies are more involved in product development.

In December 2013, Mylan and Pfizer reached an agreement on a long-acting muscarinic receptor antagonist (LAMA) and obtained commercialization rights in several markets including the United States, further enriching the original respiratory product line. .

In April 2014, Mylan entered into a global licensing agreement with US research and development company Prosonix, involving products that are GSK’s two generic drugs for the treatment of asthma brands Flixotide® and Flovent®.

In June 2015, Mylan and US R&D company Pulmatrix reached a cooperation agreement for a dry powder inhaler product for the treatment of COPD (chronic obstructive pulmonary disease), with a view to further expanding its respiratory brand medicine business. Pulmatrix will continue to complete the follow-up R&D and clinical work. Mylan has the exclusive right to commercialize the U.S. market and regards R&D results as having the right to commercialize development rights outside the U.S. market.

The cooperation between Bicon and Momenta in biosimilars has been summarized above and will not be repeated here.

Development strategy

We will further strengthen Epipen, and at the same time, strengthen research and development of patent protection products in areas such as respiratory medicine and dermatology, which currently have certain advantages, so as to form a therapeutic field with existing brand drugs and generic pharmaceutical products at the same time as individual product profits. The group’s advantages have further expanded several key areas with sales of over one billion, creating more business growth points outside of Epipen.

Strengthen the R&D and introduction of high-barrier diversified pharmaceutical products that cover a variety of dosage forms, strive to expand its existing product lines based on the advantages of tablets, and rely on strong drug certification and litigation strength to actively carry out patents The challenge will be to win the opportunity for first-to-market or early-morning markets.

Strengthen cooperation with other well-known pharmaceutical companies, such as Biocon, and use Heli to develop biosimilars through joint development or licensing.

Through targeted mergers and acquisitions to further improve its product structure and ensure that traditional areas of excellence are strengthened, it is gradually involved in new dosage forms and therapeutic areas.

Future outlook

Although Epipen continues to linger in recent days, its huge market advantage and weak competition in similar products will ensure that its growth trend will not be affected in the short term and will remain the most reliable business growth point for Mylan in the future; strong R&D and litigation The ability to further enhance product barriers on the existing basis to further optimize the structure of generic pharmaceutical products and secure first-to-market opportunities; the introduction of strategic generic acquisitions and licenses to introduce generic drugs and brand drugs will be enhanced. On the basis of its existing strengths, it further enriches the breadth and depth of its existing product line; closely cooperating with Biogene and Momenta and other biosimilar drug production and R&D companies, which makes up for Mylan’s own relative in the field. Weak strength has created conditions for rapid short-term breakthrough in this field.

As Chairman Mylan said, “The company has been on the right track toward success.” The young American guy may only need more time to prove himself. As Mylan continues to admire, “Seeing is believing”, let us witness.

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