Jun-21 Rx Recovery afoot

18
Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset Edelweiss Securities Limited Jun-21 Rx – Recovery afoot Analysis of the June quarter TRx and price data show: i) Biosimilar penetration rates are stable but Amgen has slashed prices sharply in 3 biosimilars. ii) Big Pharma is faring better. iii) Oral solids under volume pressure in the March quarter return to growth in the June quarter. Among companies: i) Sun’s specialty Rx growth gained further momentum. IL-23s outpaced IL-17s, and Cequa is the fastest growing molecule. ii) Sun’s Absorica lost 35% volume in May and June. iii) Albuterol: Cipla has 14.8% share while Lupin’s share touched 9% in the first week of July. iv) Cipla is ramping up in gTecfidera followed by Dr. Reddy’s. v) Cadila’s mesalamine franchise is stable. vi) Lupin’s gaining share in gVimovo and gApriso, but losing in famotidine. Volume pressures easing in US Gx In Exhibit 1, we have tabulated the growth of top-20 dispensed generic products in the US that show volume pressures seen in the March quarter have eased in the June quarter. We believe the Gx industry could see ~6% volume decline in Q1FY22. Sun’s Ilumya is the fastest growing biologic in plaque psoriasis. Cequa continues to grow faster than Xiidra and Restasis. Absorica lost 35% volume in two months. Albuterol: Cipla’s market share is 14.8% for Jun-21 vs. 13.5% in Mar-21 while Lupin’s market share is 7% for June; weekly data show Lupin’s share touched 9% in July. Albuterol market grew 2% YoY in Q1FY22. Cadila’s share in Lialda dropped 400bps YoY and Sun’s by ~300bps as innovator gained ~600bps. Asacol HD share stable at 92%. 11% share in gDoxil. Cipla and Dr. Reddy’s have started to ramp up in gTecfidera. Cipla’s share at 11% in June vs. Dr.Reddy at 6%; both gained at the expense of Teva and Amneal. Lupin has ramped up well in Apriso (15% share); however, it lost a 10% share in famotidine, and prices have also corrected ~25%. Biosimilars: Big players extend lead; price erosion steepening Big Pharma (Pfizer and Amgen) continue to gain biosimilars market share faster than others. In bRituxan and bHerceptin, Pfizer has overtaken several peers. Biocon’s ramp-up continues to be gradual–bNeulasta market share is 8.3%, +20bps QoQ and lower than the Jun-19 peak of 9.2%. In bHerceptin, market share is 8.7% (+60bps QoQ); Amgen has maintained its leadership but Pfizer now has second highest market share at 9%. Biocon’s share in bLantus stands at ~2.6%; glargine market slid ~5% YoY in the June quarter—lower than 11% dip in the March quarter. Amgen has become aggressive in pricing; it offers the cheapest product pegfilgastim despite being the innovator (Exhibit 5), while in trastuzumab and bevacizumab its price cuts have intensified (Exhibit 6). India Equity Research Pharmaceuticals July 23, 2021 Prescription Check SECTOR UPDATE Kunal Randeria Aashita Jain +91 (22) 6620 3040 +91 (22) 6623 3463 [email protected] [email protected]

Transcript of Jun-21 Rx Recovery afoot

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Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset Edelweiss Securities Limited

Jun-21 Rx – Recovery afoot

Analysis of the June quarter TRx and price data show: i) Biosimilar penetration rates are stable but Amgen has slashed prices sharply in 3 biosimilars. ii) Big Pharma is faring better. iii) Oral solids under volume pressure in the March quarter return to growth in the June quarter.

Among companies: i) Sun’s specialty Rx growth gained further

momentum. IL-23s outpaced IL-17s, and Cequa is the fastest growing molecule. ii) Sun’s Absorica lost 35% volume in May and June. iii) Albuterol: Cipla has 14.8% share while Lupin’s share touched 9% in the first week of July. iv) Cipla is ramping up in gTecfidera followed by Dr. Reddy’s. v) Cadila’s mesalamine franchise is stable. vi) Lupin’s gaining share in gVimovo and gApriso, but losing in famotidine.

Volume pressures easing in US Gx

In Exhibit 1, we have tabulated the growth of top-20 dispensed generic products in

the US that show volume pressures seen in the March quarter have eased in the

June quarter. We believe the Gx industry could see ~6% volume decline in Q1FY22.

Sun’s Ilumya is the fastest growing biologic in plaque psoriasis. Cequa continues

to grow faster than Xiidra and Restasis. Absorica lost 35% volume in two months.

Albuterol: Cipla’s market share is 14.8% for Jun-21 vs. 13.5% in Mar-21 while

Lupin’s market share is 7% for June; weekly data show Lupin’s share touched 9%

in July. Albuterol market grew 2% YoY in Q1FY22.

Cadila’s share in Lialda dropped 400bps YoY and Sun’s by ~300bps as innovator

gained ~600bps. Asacol HD share stable at 92%. 11% share in gDoxil.

Cipla and Dr. Reddy’s have started to ramp up in gTecfidera. Cipla’s share at 11%

in June vs. Dr.Reddy at 6%; both gained at the expense of Teva and Amneal.

Lupin has ramped up well in Apriso (15% share); however, it lost a 10% share in

famotidine, and prices have also corrected ~25%.

Sub Head

FP Table Body

Biosimilars: Big players extend lead; price erosion steepening

Big Pharma (Pfizer and Amgen) continue to gain biosimilars market share faster

than others. In bRituxan and bHerceptin, Pfizer has overtaken several peers.

Biocon’s ramp-up continues to be gradual–bNeulasta market share is 8.3%, +20bps

QoQ and lower than the Jun-19 peak of 9.2%. In bHerceptin, market share is 8.7%

(+60bps QoQ); Amgen has maintained its leadership but Pfizer now has second

highest market share at 9%. Biocon’s share in bLantus stands at ~2.6%; glargine

market slid ~5% YoY in the June quarter—lower than 11% dip in the March quarter.

Amgen has become aggressive in pricing; it offers the cheapest product pegfilgastim

despite being the innovator (Exhibit 5), while in trastuzumab and bevacizumab its

price cuts have intensified (Exhibit 6).

India Equity Research Pharmaceuticals July 23, 2021

Prescription Check SECTOR UPDATE

Kunal Randeria Aashita Jain +91 (22) 6620 3040 +91 (22) 6623 3463 [email protected] [email protected]

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Oral solids volumes seeing improvement in Jun-21 quarter

The prescription data of top 20 oral solids dispensed in the US indicate that post

negative volumes in Mar’21 quarter, Jun’21 quarter has seen mid-single digit

growth. Jun’21 quarter has seen ~6% YoY growth, which is the highest in four

quarters. Drugs such as rosuvastatin, aripiprazole, sildenafil and ondansetron have

seen double-digit YoY growth while simvastatin, montelukast and clopidogrel has

seen lower negative growth.

Improvement seen in volumes in June quarter

Q1FY20 Q2FY20 Q3FY20 Q4FY20 Q1FY21 Q2FY21 Q3FY21 Q4FY21 Q1FY22

Atorvastatin 1% 6% 6% 14% 8% 3% 4% -3% 5%

Rosuvastatin 13% 19% 20% 28% 22% 16% 17% 8% 18%

Omeprazole -7% -2% 1% 9% 10% 4% 3% -5% -2%

Aripiprazole 1% 7% 8% 17% 14% 12% 13% 6% 11%

Pantoprazole 1% 5% 6% 14% 12% 8% 7% 0% 6%

Sildenafil Citrate 39% 32% 15% 10% 10% 10% 10% 14% 14%

Duloxetine Hcl 0% 4% 5% 11% 7% 2% 3% -3% 4%

Montekulast -2% 4% 4% 19% 3% -4% -5% -18% -5%

Norvasc -1% 4% 5% 13% 7% 2% 2% -6% 3%

Lexapro 0% 6% 6% 16% 11% 10% 11% 4% 12%

Gabapentin -1% 3% 3% 8% 5% 0% 3% -2% 4%

Simvastatin -15% -10% -9% -2% -5% -10% -9% -16% -10%

Losartan Potassium 5% 3% 12% 21% 16% 6% -1% -8% 2%

Ondansentron 6% 15% 11% -3% -1% -4% -10% 1% 16%

Tadalafil 16% 42% 40% 55% 39% 32% 28% 28% 31%

Seroquel -3% 2% 2% 10% 9% 7% 8% 1% 4%

Clopidogrel -7% -2% -1% 6% 1% -6% -6% -12% -4%

Pregabalin -9% -3% 5% 15% 16% 12% 9% 4% 9%

Coreg -5% 0% 1% 8% 2% -3% -2% -9% 0%

Source: Edelweiss Research, Bloomberg

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Biosimilars TRx Trends; big players continue to outperform

Big pharma companies with biosimilars (Pfizer and Amgen) continue to gain

market share faster than others. In bHerceptin, Pfizer entered ~4-5 months after

Biocon/Mylan and had a gradual uptick initially. However, in the June quarter

Pfizer gained ~340bps ms QoQ and overtook Biocon/Mylan (+60bps QoQ) to

become #2 in trastuzumab; Amgen has comfortable retained its #1 position. In

bRituxan, Pfizer has not only overtaken Teva but also expanded its market share

gap to Teva to ~900bps.

Barring pegfilgrastim and rituximab, the first launchers have comfortably

retained leadership.

Herceptin Rx continues to decline in double-digits. However, other biologics as

well as biosimilars continue to log growth.

Biocon’s ramp-up is gradual across molecules. In bLantus, it has a 2.6% market

share 9.5 months after launch. In the June quarter, it saw ~60bps QoQ

improvement.

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Except trastuzumab and glargine, all other molecules recording strong growth

Market Rx

(Institutional) Jun-20 Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21

Pegfilgrastim 1,01,190 93,326 88,325 94,710 94,426 99,651 1,12,655 96,863 98,358 1,11,979 1,06,572 1,02,372 1,17,206

- YoY growth (month) 14% -3% -6% 2% -3% 13% 18% 3% 13% 9% 8% 7% 16%

- YoY growth

(quarter) 4% -2% 9% 8% 10%

Infliximab 6,61,021 6,84,566 6,49,329 6,67,339 6,71,849 6,46,769 6,98,212 6,54,636 6,24,357 7,41,272 7,03,695 6,61,790 7,57,177

- YoY growth (month) 13% 1% 2% 7% 1% 8% 8% -1% 8% 13% 15% 10% 15%

- YoY growth

(quarter) -1% 3% 6% 7% 13%

Trastuzumab 1,59,386 1,42,900 1,34,372 1,40,486 1,24,511 1,15,347 1,31,693 1,09,208 1,11,976 1,18,379 1,12,369 1,04,340 1,17,810

- YoY growth (month) -15% -27% -31% -24% -35% -30% -31% -34% -25% -29% -22% -27% -26%

- YoY growth

(quarter) -25% -27% -32% -29% -25%

Bevacizumab 1,56,522 1,52,508 1,48,986 1,57,721 1,57,449 1,61,115 1,82,222 1,58,116 1,62,371 1,78,779 1,76,216 1,65,851 1,90,006

- YoY growth (month) 27% 14% 11% 21% 12% 30% 35% 14% 27% 21% 29% 22% 21%

- YoY growth

(quarter) 11% 15% 25% 20% 24%

Rituximab 1,64,141 1,58,245 1,54,043 1,57,214 1,62,964 1,73,563 1,83,807 1,54,077 1,55,696 1,79,587 1,79,349 1,72,857 1,96,261

- YoY growth (month) 9% 1% -2% 3% -3% 17% 15% -4% 8% 14% 43% 25% 20%

- YoY growth

(quarter) -10% 1% 9% 6% 28%

Insulin glargine 16,25,58

5

16,28,06

2

15,72,75

9

15,18,43

5

15,37,37

3

14,73,39

4

16,10,46

7

15,14,04

7

13,94,12

3

16,01,69

1

15,03,60

9

15,04,92

7

15,82,71

4

- YoY growth (month) 3% -4% -6% -5% -8% -6% -5% -10% -10% -14% -9% -4% -3%

- YoY growth

(quarter) -1% -5% -6% -11% -5%

Source: Edelweiss Research, Bloomberg

Neulasta (pegfilgrastim): Four biosimilars have 34.6% share vs. 35.7% in Mar’21

implying that biosimilar penetration plateaued in the quarter. This is surprising

as increased vaccination in the US and opening up of clinics should have led to

biosimilar share gains at the expense of Onpro market, which remains at 51.9%

(-40bps QoQ). (Exhibit 3).

1. Market leader Coherus’s market share decreased to 18.5% (-290bps QoQ),

after peaking at 24.6% in Sep’20.

2. Biocon’s Fulphila stood at 8.3% (+20bps QoQ); this is below the 9.2% peak

market share of June 2019.

3. Sandoz’s share increased to 7.7% (+160bps QoQ). Pfizer launched its

biosimilar in Dec-20 and has a modest 1.7% share.

Amgen has become aggressive in Neulasta pricing. As per Medicare Part B data, last

two quarters have seen double-digit QoQ price declines. With rising competition

Amgen has become aggressive in Neulasta

pricing. As per Medicare Part B data, last

two quarters have seen double-digit QoQ

price declines. With rising competition

(Fresenius will launch sometime this year),

realizations are likely to become challenging

in our view.

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(Fresenius will launch sometime this year), realizations are likely to become

challenging, in our view

Biosimilar penetration in pegfilgrastim

Source: Bloomberg, Edelweiss Research

Herceptin (trastuzumab): Five biosimilars have a 50.5% share versus a 45.2%

share in Mar’21 (Exhibit 4).

1. Biocon’s Ogivri share increased marginally to 8.7% (+60bps QoQ).

2. Pfizer showed the sharpest increase with 340bps improvement QoQ. It is now

the second largest player.

3. Teva and Merck have a low-single digit market share and saw modest market

share increases.

In the March quarter, Amgen’s US bHerceptin revenues were flat QoQ at ~USD130mn

despite exit market share increasing from 41% to 43%. The extent of price erosion

can be seen from YoY numbers – while volume increased 83%, revenue increased only

35%. It expects the trend seen in Q1CY21 to continue given high competition (5

biosims).

Biosimilar penetration in trastuzumab

Source: Edelweiss Research, Bloomberg

1.96.5

7.9

9.2

7.06.3 5.8 6.1

7.47.6 8.1

8.3

02

7

13

22

2629

31 30

3432

36 36

0

8

16

24

32

40

Jun

-18

Sep

-18

Dec

-18

Mar

-19

Jun

-19

Sep

-19

Dec

-19

Mar

-20

Jun

-20

Sep

-20

Dec

-20

Mar

-21

Jun

-21

(%)

Coherus (Udencya) Biocon (Fulphila) Biosimilar share

0.1

0.7

4.05.6

7.28.1 8.7

0 26

13

22

28

38

45

50

-5

5

15

25

35

45

55

Jun-19 Sep-19 Dec-19 Mar-20 Jun-20 Sep-20 Dec-20 Mar-21 Jun-21

(%)

Amgen (Kanjinti) Biocon (Ogivri)

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Lantus (insulin glargine): Besides the brand Lantus, there are two glargine

products – Lilly’s Basaglar and Biocon’s Semglee. Sanofi’s Lantus has a 70.8%

market share (excluding Toujeo in our calculations), flat QoQ.

1. Basaglar’s market share is 26.7% (-50bps QoQ). It had reached a peak share of

30% in Nov-19. Despite a lower share, its revenue has steadily gone up over

quarters until two quarters ago.

2. Biocon is slowly gaining traction and holds ~2.6% share nine months after

launch despite having the lowest WAC among glargine players. Management

has guided that the ramp-up will be slow in CY21 and catch up in CY22

depending on the formulary coverage.

Other molecules

1. Avastin (bevacizumab) continues to erode, and the pace of biosimilar

penetration that had slackened in the last few months has intensified again.

Total biosimilar penetration is 66%; Amgen holds 47% and Pfizer 19% share.

2. Rituxan (rituximab), that had also has seen biosimilar penetration rate slacken

in the past few months, saw higher penetration. Pfizer – No.2 entrant – is now

the leader with 33.2% share and Teva’s market share is 24%. This is impressive

considering Pfizer does not have Rheumatoid arthritis on its label, which in our

view, is ~one–third of the market. Total biosimilar penetration is 58.7%.

Biosimilar pricing getting aggressive

Medicare Part B is part of the US national health insurance programme that covers

outpatient care and preventive services, among others. Exhibits 5 and 6 contain the

payment amounts that will be used to pay for Part B covered drugs for the third

quarter of 2021 (Jul–Sep). Medicare Part B reimbursement rates for the Jul–Sep

quarter indicate:

QoQ price decline in biosimilars has steepened in a few molecules. In fact, it’s

not just biosimilars but also innovator biologics that have been aggressive with

pricing.

Neulasta and biosimilars: Innovator Amgen’s prices have declined 12% QoQ

(following a 9% QoQ decline last qtr) and 40% YoY; this is the second-highest

decline since biosimilars entered this molecule. This also widens the discount

(7.5%) of Neulasta to other biosimilars. Coherus prices have been flat, Biocon has

seen a 5% QoQ decline and Sandoz ~2%.

Herceptin and biosimilars: The pace of price decline intensified for the ‘more

expensive’ biosimilars. _Biocon’s Ogivri price increased 5% QoQ. However, other

biosimilars like Teva and Merck which were among the more expensive

biosimilars they suffered 19% QoQ and 10% QoQ price declines, respectively, and

thus narrowed the gap to other biosimilars. Amgen is now the cheapest

biosimilar as it saw a sharp 10% QoQ decline.

Other molecules: Remicade & biosimilars saw lower QoQ decline than previous

quarters while Avastin saw a similar decline. Biocon is expected to get

approval/launch bAvastin after plant inspection.

As we have been flagging, intensifying competition has led to continual price

declines in biosimilars. In several cases, despite no new players, prices have been

eroding 4–6% QoQ. Amgen, in particular, has been aggressive with prices; this

quarter has seen Amgen having the steepest price declines in all the molecules it is

present in and making it the lowest cost supplier.

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In our recent ‘US and EU pharma roundup’ we note players such as Amgen have seen

revenue declining in bHerceptin despite higher market share while Coherus is

expecting its bNeulasta revenue to go down YoY in CY21 despite steady-to-

increasing market share. Also note that bHerceptin Rx have been declining at ~30%

YoY over the last few months—while part of it can be explained by Covid-related

slowdown, the molecule class has been facing double-digit volume pressures for

long, even prior to Covid..

Average Selling Price (ASP) in Medicare Part B in USD

ASP Medicare Part B reimbursement

Sep-18 Dec-18 Mar-19 Jun-19 Sep-19 Dec-19 Mar-20 Jun-20 Sep-20 Dec-20 Mar-21 Jun-21 Sep-21

Neulasta (pegfilgrastim) reimbursement price for 0.5mg

Amgen (innovator) 393 391 390 388 377 369 355 332 317 298 257 234 206

Biocon 369 358 350 333 327 312 308 294 269 248 237 222

Coherus 358 359 347 337 322 302 287 268 251 252

Sandoz 317 306 298 277 271

Pfizer 337 314

Herceptin (trastuzumab) reimbursement price for 10mg

Roche (innovator) 104 104 107 107 107 107 106 104 102 100 98 94 91

Roche - Hylecta (innovator) 80 82 79 78 77 75 75 72 72

Amgen 91 91 82 81 79 72 66 59

Biocon 91 91 93 76 73 61 63

Pfizer 83 83 83 74 68 65

Teva 96 92 86 82 67

Merck 91 92 88 80 72

Remicade (infliximab) reimbursement price for 10mg

Remicade 84 79 77 72 65 63 57 56 51 48 45 42 41

Pfizer (Inflectra) 65 61 57 54 51 49 48 48 47 44 43 41 40

Merck (Renflexis) 69 64 62 59 55 53 52 50 49 45 42 41 40

Amgen (Avsola) 52 52 50 49

Avastin (bevacizumab) reimbursement price for 10mg

Roche (Avastin) 81 81 81 81 81 80 78 76 75 73 71

Amgen (Mvasi) 70 70 63 62 61 57 53 49

Pfizer (Zirabev) 63 63 62 59 57 55

Source: CMS, Edelweiss Research

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Price erosion (QoQ) in Medicare Part B

ASP Medicare Part B reimbursement ASP Medicare Part B reimbursement (QoQ price decline)

Sep-18 Dec-18 Mar-19 Jun-19 Sep-19 Dec-19 Mar-20 Jun-20 Sep-20 Dec-20 Mar-21 Jun-21 Sep-21

Neulasta (pegfilgrastim)

Amgen (innovator) 5% -1% 0% -1% -3% -2% -4% -6% -4% -6% -14% -9% -12%

Biocon n/a n/a -3% -2% -5% -2% -5% -1% -4% -9% -8% -5% -6%

Coherus n/a n/a n/a n/a 0% -3% -3% -4% -6% -5% -7% -6% 0%

Sandoz n/a n/a n/a n/a n/a n/a n/a n/a n/a -4% -2% -7% -2%

Pfizer

Herceptin (trastuzumab)

Roche (innovator) 3% 0% 3% 0% 0% 0% -1% -2% -2% -3% -2% -4% -3%

Roche - Hylecta (innovator) n/a n/a n/a n/a n/a 2% -3% -2% -1% -3% -1% -3% 0%

Amgen n/a n/a n/a n/a n/a n/a 0% -10% -1% -3% -8% -9% -10%

Biocon n/a n/a n/a n/a n/a n/a n/a 0% 3% -18% -4% -17% 5%

Pfizer n/a n/a n/a n/a n/a n/a n/a n/a 0% 0% -11% -8% -5%

Teva n/a n/a n/a n/a n/a n/a n/a n/a n/a -5% -6% -5% -19%

Merck n/a n/a n/a n/a n/a n/a n/a n/a n/a 1% -4% -9% -10%

Remicade (infliximab)

Remicade 1% -6% -3% -6% -10% -2% -10% -3% -8% -7% -6% -7% -2%

Pfizer (Inflectra) -7% -6% -7% -5% -6% -4% -3% 0% -1% -7% -2% -6% -1%

Merck (Renflexis) -2% -7% -4% -4% -8% -2% -3% -4% -2% -8% -6% -3% -3%

Amgen (Avsola) n/a n/a n/a n/a n/a 0% -3% -2%

Avastin (bevacizumab)

Roche (Avastin) n/a n/a n/a 0% 0% 0% -1% -1% -1% -3% -2% -4% -3%

Amgen (Mvasi) n/a n/a n/a n/a n/a n/a 0% -10% 0% -2% -7% -7% -8%

Pfizer (Zirabev) n/a n/a n/a n/a n/a n/a n/a n/a 0% -1% -4% -4% -4%

Source: CMS, Edelweiss Research

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Albuterol (USD900mn market): Cipla maintains comfortable lead

Mar’21 quarter witnessed one of the weakest seasons that saw volumes declining

13–15% between January to March. However, April was the last month of decline

and May onwards volumes showed a YoY uptick; May TRx grew 8% YoY while Jun

TRx grew 11% YoY.

Albuterol volumes recovered from May’21

Source: Bloomberg, Edelweiss Research

Cipla’s uptake in albuterol remains impressive. Cipla market share touched

15.1% in the week of 9th July while Lupin also made strong gains with market

share touching 9%. This is in-line with Lupin’s guidance that maret share would

pick up post resolution of device supply issues.

Cipla’s ramp-up has been faster than Lupin. 45 weeks after launch, Lupin has 9%

market share while Cipla had 12.7%. This is despite Cipla’s RLD having a much

smaller market and Lupin’s lau nch coincided with Perrigo’s withdrawal.

However, Lupin has started catching up after a lethargic start. In the last 6 weeks,

Lupin’s market share has risen from 5% to 9%.

The interchangeability among brands that we had seen earlier, has become more

evident after the Perrigo’s withdrawal. Teva has been the biggest beneficiary of

Perrigo’s withdrawal (same RLD – ProAir) followed by Cipla (Proventil RLD)

Prasco (AG of Ventolin) and ProAir brand has lost share.

In the last 15 months (post Cipla’s launch), Ventolin and its generics have lost

around 1200bps market share (from 44% to 32%). ProAir and generics have

gained ~400bps to 52% share while Proventil and generics have gained ~800bps

to 16%. The main reason is that Ventolin had only 1 AG in the market and no

other generic while ProAir and ProVentil had both AG as well as another generic.

Moreover, Cipla’s share gain in albuterol market has expanded the overall

Proventil category, indicating product interchangeability.

Overall albuterol TRx in this quarter is up ~2% YoY.

-40%

-20%

0%

20%

40%

60%

0

1,600,000

3,200,000

4,800,000

6,400,000

8,000,000

Ap

r-1

9

Jun

-19

Au

g-1

9

Oct

-19

Dec

-19

Feb

-20

Ap

r-2

0

Jun

-20

Au

g-2

0

Oct

-20

Dec

-20

Feb

-21

Ap

r-2

1

Jun

-21

Albuterol market TRx YoY growth (RHS)

Recovery

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10 Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset

Cipla is comfortably ahead of Lupin…

Source: Edelweiss Research, Symphony

…but Lupin ramped up sharply in last few weeks

Source: Edelweiss Research, Symphony

Proventil has gained significant market share from Ventolin

Source: Bloomberg, Edelweiss Research

0% 0%1%

3%4% 4%

3% 3% 4% 4%5%

7%6%

7%8%

9%

10%11%

12% 12%13% 14%

15% 15%

0%

4%

7%

11%

14%

18%

Jul-

20

Au

g-2

0

Sep

-20

Oct

-20

No

v-2

0

Dec

-20

Jan

-21

Feb

-21

Mar

-21

Ap

r-2

1

May

-21

Jun

-21

Lupin Cipla

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

02

-10

-20

20

22

-10

-20

20

11

-11

-20

20

01

-12

-20

20

21

-12

-20

20

10

-01

-20

21

30

-01

-20

21

19

-02

-20

21

11

-03

-20

21

31

-03

-20

21

20

-04

-20

21

10

-05

-20

21

30

-05

-20

21

19

-06

-20

21

09

-07

-20

21

Lupin weekly and monthly TRx (of total albuterol market)

48% 51%

44% 33%

8%16%

0%

20%

40%

60%

80%

100%

Jul-

19

Sep

-19

No

v-1

9

Jan

-20

Mar

-20

May

-20

Jul-

20

Sep

-20

No

v-2

0

Jan

-21

Mar

-21

May

-21

ProAir HFA and generic Ventolin and generic Proventil and generic

Page 11: Jun-21 Rx Recovery afoot

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Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset 11

Specialty: positive trends continue in Ilumya & Cequa

Ilumya: Ilumya, which was worst hit during the pandemic, has picked up growth.

1. Sun’s specialty recovery continued strongly in Q1FY22. Ilumya +38% QoQ (+18%

QoQ in Q4FY21); its IL-23 counterpart Skyrizi has grown at +28% QoQ.

2. Sun’s Ilumya becomes the fastest growing molecule in this class. Ilumya TRx

growth in Q1FY22 was at 101% YoY. Abbvie’s Skyrizi which was growing on

similar lines is now growing slower than Ilumya at 77% YoY, albeit on a higher

base.

Cequa: After volume dip seen in Jan’21 and Feb’21, Cequa clocked highest TRx in

Jun’21 with +79% YoY growth. For the quarter ended Jun’21, Cequa growth was

103%, ahead of Xiidra’s 28% and Restasis’ 11%. Cequa list price increased by 4%

in Apr’21 which reduces Restasis list price premium from ~22% in Jan’21 to 17%.

Restastis list price increased by 5% in Jan’21.

Absorica (~USD135mn pre-genericisation): Actavis which had settlement to

launch on 27-Dec-2020, received final approval in Mar’21 and launched generic

Absorica on 1-April 2021. Following Actavis, Upsher Smith launched its generic in

May’21. This led to ~35% YoY decline in Absorica TRx; however, excluding the LD

ramp-up the decline in high dose TRx was ~54% in May and June. ~38% of total

Absorica Rx comprises low-dose Absorica (Absorica LD).

Ilumya performance continues to improve

Source: Edelweiss Research, Bloomberg

341

493 533430

1021

1275

0

300

600

900

1200

1500

Apr-19 Jun-19 Aug-19 Oct-19 Dec-19 Feb-20 Apr-20 Jun-20 Aug-20 Oct-20 Dec-20 Feb-21 Apr-21 Jun-21

Retail TRx Insti TRx

Ilumya trajectory is picking up with Jun Qtr TRx growth at 38% QoQ/101% YoY. In Jun month, TRx grew 19% MoM; 102% YoY

Page 12: Jun-21 Rx Recovery afoot

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Ilumya becomes fastest growing molecule in IL-23 class

Source: Edelweiss Research, Bloomberg

Cequa seeing strong uptick in TRx growth

Source: Bloomberg, Edelweiss Research

Absorica TRx declining sharply post genericisation

Source: Bloomberg, Edelweiss Research

784 712 771 860 896 925 842 877 1083 1033 1103 1172 12351514

1808

24892988 2794

25292976

3267 31743454

3840 3696

4573

32143590

5046

6065

0

1500

3000

4500

6000

7500

Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21

Ilumya Total TRx Skyrizi Total TRx

. Ilumya +38% QoQ; its IL-23 counterpart Skyrizi has grown on similar lines (+28% QoQ).

6685

3840 43885351

5929 58816682

8095 82139562

8150 7875

9652 9101 88459583

0

3000

6000

9000

12000

15000

Mar

-20

Ap

r-2

0

May

-20

Jun

-20

Jul-

20

Au

g-2

0

Sep

-20

Oct

-20

No

v-2

0

Dec

-20

Jan

-21

Feb

-21

Mar

-21

Ap

r-2

1

May

-21

Jun

-21

CEQUA

Cequa clocked highest TRx in Jun'21 with 8% MoM growth.In Jun Qtr, Cequa TRx was 2x YoY as against 6-11% seen in other cyclosporines and 28% in Xiidra

0

3000

6000

9000

12000

15000

Oct

-19

No

v-1

9

Dec

-19

Jan

-20

Feb

-20

Mar

-20

Ap

r-2

0

May

-20

Jun

-20

Jul-

20

Au

g-2

0

Sep

-20

Oct

-20

No

v-2

0

Dec

-20

Jan

-21

Feb

-21

Mar

-21

Ap

r-2

1

May

-21

Jun

-21

TRx

Absorice high dose Absorica low dose

Page 13: Jun-21 Rx Recovery afoot

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Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset 13

Mesalamines: Cadila holding fort; Sun share under pressure in

gLialda

In gLialda, Sun which was aggressively gaining market share at the expense of

Cadila has started to show signs of pressure. After achieving peak share of 12.4%

in Jan’21, Sun’s share has now slipped to 9%. Cadila’s market share too has

slipped from 55% to 51%. Surprisingly, innovator Takeda has gained at the

expense of both Cadila and Sun.

Asacol HD: Overall volumes down 6% YoY. However, the rate of decline has

eased – Mar’21 qtr saw ~13% YoY decline. Cadila’s market share has slipped from

~97% in Mar’21 to 92%. l

Apriso: Lupin has ramped up well with 15.5% market share, up 100bps QoQ.

Alkem has got US FDA approval for a generic version of Apriso and will be

launching shortly. Importantly, Alkem's Apriso ANDA is backed by its own DMF

i.e. it is backward integrated in this molecule. Apriso market size is $320mn as

per IQVIA, which could potentially translate to $200-220mn at the manufacturer

level, in our view. Currently there are 2 Authorised Generics (Lupin and Teva) and

1 generic (Mylan) in the market. Competition is likely to be limited and we expect

$25-30mn from this product at substantially higher margins.

Lialda: Cadila slipping share to 51%+ share; Sun also losing share

Source: Bloomberg, Edelweiss Research

40 45 47

53 58 59 59

55 55 56 53 54 52 53 55 56 54 52 51

- 1 2 2 2 1 1 3 3 4 8 8 10 12 12 10 8 8 9

0

15

30

45

60

75

Dec

-19

Jan

-20

Feb

-20

Mar

-20

Ap

r-2

0

May

-20

Jun

-20

Jul-

20

Au

g-2

0

Sep

-20

Oct

-20

No

v-2

0

Dec

-20

Jan

-21

Feb

-21

Mar

-21

Ap

r-2

1

May

-21

Jun

-21

Mar

ket

shar

e (%

)

ZYDUS SUN

Page 14: Jun-21 Rx Recovery afoot

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14 Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset

CDH market share slipped marginally to 92% in Asacol HD

Source: Bloomberg, Edelweiss Research

Lupin ramping up well in gApriso with 15.5% market share

Source: Bloomberg, Edelweiss Research

Other key drugs TRx

Dr.Reddy’s Suboxone market share is constant at 18%. Ciprodex market share

increased to ~29% (from 25%) as Sandoz grabs 67% share in Jun’21 (flat QoQ).

Market share plateauing in gKuvan tablets (three player market) with DRRD

share at 15% vs. Endo at 57%.

Dr. Reddy's market share in key launches

Market size at time of

launch (USD mn) Jun-20 Sep-20 Dec-20 Mar-21 Jun-21

Suboxone 1500 18% 18% 18% 18% 18%

Vimovo 410 26% 25% 27% 33% 42%

Syprine 400 0% 1% 19% 17% 10%

Colcrys 490 2% 2% 3% 4%

Ciprodex 450 18% 23% 25% 29%

Kuvan Tablets 150 15% 16% 13%

Source: Edelweiss Research, Bloomberg

Note: Market size is as per IQVIA data. At manufacturer level, the market size will be lower

0%

20%

40%

60%

80%

100%

Feb

-19

Ap

r-1

9

Jun

-19

Au

g-1

9

Oct

-19

Dec

-19

Feb

-20

Ap

r-2

0

Jun

-20

Au

g-2

0

Oct

-20

Dec

-20

Feb

-21

Ap

r-2

1

Jun

-21

ALLERGAN PLC. ZYDUS PHARMACEUTICALS, INC

0.6

4.0

6.4

9.810.7

11.7 12.2 12.3 12.9 13.314.2

15.616.5

15.5

0

4

8

12

16

20

May

-20

Jun

-20

Jul-

20

Au

g-2

0

Sep

-20

Oct

-20

No

v-2

0

Dec

-20

Jan

-21

Feb

-21

Mar

-21

Ap

r-2

1

May

-21

Jun

-21

Lupin market share (%)

Page 15: Jun-21 Rx Recovery afoot

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Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset 15

Tecfidera (Dimethyl Fumarate): Despite 8 generic players, innovator Biogen

retains 56% market share (market size: ~USD 3.6bn pre-genericization). Among

Indian players Cipla and Dr.Reddy have ramped up aggressively in the last couple

of months. Surprisingly, the ms gains have come at the expense of Teva and

Amneal and not the innovator.

Cipla and Dr.Reddy ramping up in gTecfidera

Source: Edelweiss Research, Bloomberg

Copaxone: Mylan/Natco has gained 800bps market share to 49% in 40mg market

while Sandoz has ~5%. In the 20mg market, Mylan has 25% share while Sandoz

has 28%. 40mg prescriptions are ~65% of the total Copaxone. However, overall

copaxone volumes are on a constant decline. In Q1FY22, overall TRx declined by

20% YoY.

Doxil: Cadila had a slow start but has ramped up in Q1FY22 with 5% market share

in Mar’21 going up to 11% in Jun’21. Sun’s market share has gradually come

down from ~26% to 19% while Dr. Reddy’s share has come down from ~27% to

~23%.

Famotidine oral suspension: Famotidine oral suspension Rx have gone up 10x

from Sep-2019 following the FDA banning ranitidine in late Sep-2019 and

increasing use in Covid treatment protocol. Currently, Lupin is the market leader

with ca. 99% share in the oral suspension market; Perrigo and Cadila are other

players. Lupin could potentially be generating ca. USD75-80mn or 11-12% of its

US sales from this product, in our view. In May’21, Novitium received final

approval for famotidine oral suspension in the US. Cadila has also become

aggressive and has gone for a sharp 25% list price cut.

Lupin's market share has eroded ~10pp in 1 month...

31-03-2021 30-04-2021 31-05-2021 30-06-2021

Lupin 100 100 99 91

Cadila 0 0 0 6

Novitium 0 0 0 3

Source: Edelweiss Research, Bloomberg

1.2 1.1 1.31.7 1.7 1.8

3.3

7.8

10.4

1.10.5

0.0 0.1 0.2 0.3

2.3

5.05.9

0

3

5

8

10

13

Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21

Mar

ket

shar

e (%

)

Cipla Dr.Reddy

Page 16: Jun-21 Rx Recovery afoot

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16 Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset

...while price erosion is ~25%

Source: Bloomberg, Edelweiss Research

2.8

2.0

pre-Apr 2020 Apr-21

List price of famotidine suspension (USD)

Page 17: Jun-21 Rx Recovery afoot

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Edelweiss Research is also available on www.edelweissresearch.com, Bloomberg - EDEL, Thomson Reuters, and Factset 17

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Aditya Narain

Head of Research

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