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Dispensed TRx: Total US Industry, MAT, March 2017 Lupin is ranked 5th in the US industry

standings of all pharmaceuticals

Dispensed TRx: Total US Unbranded Generics, MAT, March 2017 Lupin is ranked 4th
in the US industry standings of unbranded generics

Top 10 companies based on unbranded generics


U.S. market share during 2014-2015*
https://www.statista.com/statistics/522095/market-share-of-unbranded-generics-by-
top-20-companies-in-the-us/
Source: http://www.fiercepharma.com/special-report/top-15-generic-drugmakers-2016

The momentum of Lupins sustained growth year over year is a result of a valuable
pipeline, solid customer relationships and flawless execution. Last fiscal year, Lupin
launched 18 new products. The majority of Lupins products are vertically integrated
which ensures quality control throughout each step of product development and
manufacturing. This gives Lupin an unparalleled advantage over its competitors, as it is
able to control its supply chain while offering competitive pricing.
Source:
http://www.pharmacytimes.com/publications/supplement/2017/genericsupplement2017/l
upin-pharmaceuticals

1. Teva
Headquarters: Petah Tikva, Israel 2016 generic drug sales: $9.8 billion

Being the worlds largest generic drug player certainly comes with its challenges. With 57,000
full-time employees around the globe, Israels Teva Pharmaceutical Industries ranked No. 1
among the worlds top generic drugmakers, raking in $9.8 billion with its copycats last year.
Thats in line with the drugmakers finish in FiercePharmas 2014 ranking, and Teva has bulked
up even further in 2016, purchasing Allergans generics for $40.5 billion. But industry bragging
rights werent enough for Tevas restive shareholders. Before the drugmaker even closed the
deal in August, it faced investor angst over concerns it paid too much. They grossly overpaid,
theres no doubt about it, one investment banker told the Financial Times last year. Those
concerns would prove to be just the start of Tevas recent troubles as problem after problem
cropped up. The drugmaker said goodbye to its CEO, settled a massive bribery case with U.S.
officials and lowered its 2017 guidance, all within a few months. Facing those challenges, an
Israeli newspaper in March reported that Teva is considering thousands of layoffs. Meanwhile, in
an attempt to combat the trends so badly hurting the industry, Teva last fall committed to a high
number of launches1,500 per yearto propel its business to 5% growth in the years to come.
Our global pipeline of generic products positions us for an increasing number of first-tofile
opportunities and other key generic launches, as well as further expanding our product
portfolio, Teva wrote in its annual 20-F filing with the Securities and Exchange Commission.
Overall, the drugmaker has 330 product applications awaiting FDA approval, according to that
filing, and 71 tentative nods from the agency. Teva said its the first-to-file company for 95 of
those products, which comes with a 6-month monopoly and its attendant revenue boom. And it
disclosed a staggering 1,655 generic drug approvals in Europe last year. The company is just
kicking off its launch of AirDuo RespiClick and an authorized generic of that product, which is an
alternative to GlaxoSmithKlines respiratory giant Advair that Evercore ISI analyst Umer Raffat
called a very important launch for Teva. Like Mylan and several other generics firms, Teva is
under investigation for possible generic pricing collusion.

While Teva pressures branded drugmakers with its cheap copycats, the company faces its own
generic threat with its branded Copaxone, a blockbuster MS med. Already fighting off copycats
to its original Copaxone formula, Teva is expected to soon face generic erosion on its follow-up
40 mg version. After losing numerous court battles to defend that med, the drugmaker caught a
lucky break when Momenta and partner Sandoz received a complete response letter from the
FDA related to manufacturing.

2. Mylan
Headquarters: Bunschoten, The Netherlands 2016 generic sales: $9.43 billion

For some time, Mylans corporate image will be linked with its damaging EpiPen pricing
controversy. But aside from all that negative attention, it has a booming generics engine that
generated $9.43 billion in sales last year, according to Evaluate analysts. The drug maker had a
rough time in 2016 after its EpiPen price increases, made over several years, went public. To
appease critics, the company launched an authorized generic and amped up its patient
assistance programs. Still, Mylan worked through a deluge of bad PR and is now working to
finalize a settlement with the U.S. Department of Justice over alleged Medicaid overcharges on
its med. Despite the controversy, Mylan turned in 18% growth last year to $11.1 billion in total
sales, expanding at a clip the companys larger pharma peers would love to duplicate. But it
wasnt all sunny, as pricing presented a challenge and will continue to pressure results in 2017,
President Rajiv Malik said in an accompanying statement. We continued to see erosion both
globally and in U.S. generics in the mid-single digits which was in line with our expectations, and
we continue to expect a comparable environment in 2017 given the breadth and make-up of our
global portfolio, he said. For 2017, Mylan is expecting 17% growth at the midpoint of its
revenue projections. At the end of 2016, Mylan had more than 35,000 employees around the
globe and 247 generic drug applications pending at the FDA, representing nearly $100 billion in
sales for the branded versions. Needless to say, its a complicated outfit constantly seeking to
challenge Big Pharmas patents, master manufacturing and supply chain efficiencies, and steal
market share from expensive branded meds. Its also pushing into biosimilars, with a Herceptin
biosim on the market in India and applications pending in the U.S.

The company has been on a bit of an M&A spree lately, last year picking up Swedish drugmaker
Meda for $7 billion and a group of topical skin meds from Renaissance Holdings for $1 billion.
With savings to achieve from its M&A spree, the drugmaker late last year said itd be chopping
up to 3,500 jobs. Mylan is among the companies under investigation by federal officials for
potential collusion on generic drug pricing. But despite the controversies, the company
announced a $97 million exit package for non-executive director Robert Coury, who stopped
being an employee in June. Mylan first started making generic drugs in the 1960s and today
markets more than 7,500 products, according to its website, with offerings in virtually every
therapeutic area.

Novartis Sandoz unit


Headquarters: Basel, Switzerland 2016 generic sales: $9 billion

With branded and generic sales near the top of the pack, Novartis holds somewhat of a unique
position. The drugmaker turned up fourth in FiercePharmas review of top drugmakers by overall
revenue last year, and its Sandoz outfit landed in third place for generic sales. Sandoz turned in
$9 billion in generics revenue last year, according to Evaluate. With its $1 billion in biosimilar
sales included, Sandoz raked in $10.1 billion, good for 1% growth versus the previous year. The
companys numbers illustrate pricing pressures felt around the generics industry. Sandoz grew
sales volumes by 9% last year, but that was partially offset by a 6% erosion in price. Execs expect
that trend to continue through 2017. For the current year, Novartis execs are calling for low-
single-digit growth from Sandoz, as pricing challenges hitting its peers continue to hurt its own
business. Last November, the drugmaker was rumored to be considering a purchase of New
Jersey-based drugmaker Amneal to further build up its generics business, with RBC Capital
Markets analyst Randall Stanicky writing at the time that pressure for generics M&A will only
continue because of pricing erosion. Stanicky wrote that the sector needs to consolidate as one
of the offsets to this cyclical pressure that we think can get worse. As of yet, however, Novartis
hasnt struck a deal in generics.

3. Pfizer
Headquarters: New York, NY 2016 generic sales: $4.57 billion

Below the worlds top three generics companies, scale in the industry drops off somewhat. Pfizer
landed at the No. 4 spot globally, and though the New York drug giant gets the bulk of its sales
from branded meds, it has an important generics and unbranded drugs business that turned in
$4.57 billion in sales last year, according to Evaluate. Pfizers critical move relating to generics
last year was its decision to remain as one company, rather than splitting up as analysts and
industry-watchers had long anticipated. With that move, the companys branded and off-patent
medicines stayed under the same roof. Back in 2015, the drugmaker bulked up in injectable
generics with its purchase of Hospira, worth $15 billion. As industry-watchers know, the
company had been eagerly looking for deals after its megamerger bid for the U.K.s AstraZeneca
fell through. Pfizers Essential Unit, as its called, is expected to generate strong consistent cash
flow by providing patients around the world with access to effective, lower-cost, high-value
treatments, including generic sterile injectables, according to Pfizers recent 10-K filing (PDF)
with the Securities and Exchange Commission. With more than 220 injectable meds in the group,
plus other off-brand products, Pfizer is looking to Essential Health as a major growth driver
going forward, according to its website. While challenging rivals with generics, Pfizer is expecting
competition from Teva and Mylan on its notorious blue pill, Viagra, later this year. Pristiq, an
antidepressant, already went over the patent cliff back in March.

4. Endo International
Headquarters: Dublin, Ireland 2016 generic sales: $2.56 billion

Endo didnt even make it to the top 20 generics companies by 2014 revenue. Then, the merger
with Par happened, but the joy didnt last long; its stock started tumbling like an avalanche as
guidance slashing, regulatory setbacks, new rivals, generics price erosion and job cuts all
contributed to its fall. Lets go back to May 2015, when Endo announced the $8 billion
acquisition of Par Pharmaceutical. It gave Endo some 100 products from Par, including many
high-barrier-to-entry, profitable generic products. The deal looked promising for Endo as Par
enjoyed $1.3 billion in revenue in 2014, with compound annual revenue growth rate of 12.2%
from 2012 to 2014. Endos stock traded at around $85 at that time, but would drop to $14 in a
year. In May 2016, Endo slashed its full-year top-line guidance from the $4.32 billion to $4.52
billion stated in its 2015 full-year financial results to $3.87 billion to $4.03 billion, and dialed back
adjusted diluted EPS from $5.85 to $6.20 to $4.50 to $4.80. Then-CEO Rajiv De Silva cited new
rivals on the market, greater-than-expected generics price erosion and regulatory delays as
reasons for the lackluster performance. The final 2016 revenue for Endo? Just $2.56 billion. But
that was later. Shares plunged about 40% at the news, though they had already been on a
downward trajectory comparable with those of Valeant. De Silvas former title as COO of the
Canadian drugmaker and a similar acquisition-heavy, debt-building strategy helped make the
connection, and was probably part of the reason behind his ouster in September, followed by
former EVP and CFO Suketu Upadhyays departure in November. With that readjustment in
May, Endo also announced a restructuring plan to close plants and cut 740 jobs. The job-cutting
spree continued in December 2016 as it sidelined its once-core pain business, tossing 375 full-
time and contracted jobs. In January 2017, the company kicked off a new round of restructuring
that claimed 90 jobs primarily within corporate functions and branded pharma R&D. The Dublin
drugmaker also took several hits for its star med Opana ER since 2016 as the whole country
raged over an opioid epidemic. In March 2016, the company settled a case with a New York state
prosecutor, agreeing to pay $200,000 and not soft-pedal the risks of taking the drug or oversell
its crush resistance.

Following controversy over the meds role in a 2015 HIV outbreak in southern Indiana, in August
2016 the company withdrew a supplemental NDA that would label Opana ER as abuse
deterrent. The FDA found that the meds new formulation may have made it easier for
injection, and an advisory committee at the agency decided in March 2017 that the drugs
benefits are overshadowed by misuse, abuse and diversion. Possible restrictions as far as
complete takedown could follow. Now, its up to new CEO Paul Campanelli, the former CEO of
Par, to turn things around. But it will take time to right it from a company that grew through
debt-fueled M&A to one that will primarily focus on organic growth, Campanelli said on the
companys 2016 earnings call. The companys $3.45 billion to $3.6 billion 2017
revenue outlook fell short of the consensus $3.83 billion estimate, while an adjusted earnings
range of $3.45 to $3.75 per share didnt come close to Wall Streets $4.29 prediction.

5. Lupin
Headquarters: Mumbai, India 2016 generic sales: $2.48 billion (estimate)

2016 was a mixed year for Lupin. It completed the acquisition of U.S.-based Gavis in March 2016,
obtaining its first manufacturing site in the U.S., along with some 60 ANDA filings pending
approval with the FDA at that time; but a Form 483 for its Goa plant and two large-scale drug
recalls because of failed ingredients were setbacks. For the entire fiscal year ending March 2017,
Evaluate estimated that Lupins total generic revenue reached $2.48 billion. To put that into
context, the companys entire revenuegeneric and brandedin the previous fiscal year was
$2.09 billion. That volume boost was largely thanks to the Gavis purchase. The two first struck
the $880 million deal in July 2015. In what Lupin touted as the largest acquisition made by an
Indian pharmaceutical company in the U.S., Lupin broadened its portfolio to more than 120
marketed products, nabbed a manufacturing and R&D site, a packaging and distribution facility
and 62 ANDA filings with the FDA worth more than $9 billion. Lupin said that upon completion of
that buy, the company has the fifth-largest pipeline of ANDA filings with the U.S. FDA (the
branded counterparts of those generics total a $63.8 billion market), plus 45 first-to-file
products, including 25 exclusive ones. It immediately tapped industry veteran Kurt Nielsen,
Ph.D., to lead the new U.S. business called Lupin Somerset. He was formerly with Sandoz as
global head of product development and VP of U.S. product development, portfolio and launch
management.

For the fiscal year from April 2016 to March 2017, Lupin also launched 13 generic products in the
U.S. Among them is a generic of Pfizers antidepressant Pristiq, which reeled in $578 million in
U.S. sales for the Big Pharma in 2016. But Mylan, Actavis and Sandoz are also eying the same
product. Lupin also revealed in early 2016 that it is building a dedicated oral solids plant in
Tottori, Japan, that would be able to produce 2 billion tablets a year. Japan represents the Indian
drugmakers third-largest market, following the U.S. and India, and the countrys growing
demand for generics is beyond the ability of its current facility in Sanda, Japan. It also indicated it
was seeking out potential M&A targets in Japan. But it was not all smooth sailing for Lupin. First,
there were still no words about completion of the acquisition of Russian generic drugmaker ZAO
Biocom. Lupin announced in July 2015 that it had a deal to buy 100% equity stake in the Russian
company, but regulatory roadblocks have gotten in the way and it has yet confirm the deal has
been completed. Perhaps not as deep in the FDA regulatory quagmire as its fellow Indian
drugmaker Sun Pharma, Lupin also has its own share of problems to worry about. The FDA cited
nine observations in a Form 483 sent to Lupins Goa, India, plant in March 2016. After clearing
the concerns in November, the plant was cited again after an inspection this year.

Source:

https://pages.questexweb.com/rs/294-MQF-
056/images/Top%2015%20Generic%20Drugmakers%20of%202016.pdf
North America
Lupin sales in North America grew by 82.3% to Rs. 21,886 m. during Q1 FY2017 as compared to Rs. 12,004
m. during Q1 FY2016; contributing 51% of Lupins global sales.

US sales grew by 78.9% to USD 322 m. during Q1 FY2017 as compared to USD 180 m. during Q1
FY2016. US sales declined by 1% during Q1 FY2017 as compared to USD 325 m. during Q4 FY2016
The Company launched 3 products in the US market during the quarter. The Company now has
123 products in the US generics market
Lupin is now the market leader in 46 products marketed in the US generics market and amongst
the Top 3 in 80 of its marketed products (market share by prescriptions, IMS Health, June 2016)

Source: http://www.lupin.com/record-sales-and-profits-lupin-quarter-1-fy2017.php

Figure 2: U.S. Snapshot Population: 322 million Population over 65: 48 million (15%) Total
healthcare expenditure: $3.12 trillion (17.4% of GDP) Government healthcare expenditure:
$1.49 trillion (47% of total) Private healthcare expenditure: $1.63 trillion (52% of total) Total
pharmaceutical sales: $333 billion (1.9% of GDP; 10.7% of total healthcare exp.) Per capita
pharmaceutical sales: $1036 Generic sales: $70 billion (21% of total sales) Patented sales: $244
billion (70% of total sales) OTC sales: $19 billion (6% of total sales)

Source: https://www.trade.gov/topmarkets/pdf/Pharmaceuticals_Top_Markets_Reports.pdf

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