16
ICICI Securities – Retail Equity Research Monthly Sector Update October 11, 2019 Health Check Scepticism encircles generic players with flurry of cGMP issues In 2019, Indian companies received seven warning letters, ~10 Official Action Indicated (OAI) and a number of adverse observations from USFDA. In a recent update, Aurobindo Pharma’s Unit-7 has received Form 483 from USFDA with seven observations. The USFDA conducted cGMP related inspection at this unit from September 19-27, 2019. As per media reports, this plant is contributing 25-30% to US revenues. The company has ~33 pending USFDA approvals as of Q1FY20 from Unit VII. We believe the observations are critical and the company is likely to face further remedial action from the USFDA like warning letter or in worst case scenario an import alert. We await further action from the USFDA. Although the company owns one of the best US generic ecosystem (lower product concentration- top 25 products account for just ~40% of US sales; growing non-oral franchise; number of alternate plants at the disposal; ~70% own API source), the overhang of a fourth plant coming under scrutiny within a span of few months is taking huge toll on the stock. In another cGMP related incident, Torrent's Indrad (Gujarat) facility received a warning letter from the USFDA. We were expecting this warning letter after it received OAI status from the USFDA in August 2019. The management expects no impact on existing supply and revenue generated from the facility. As per media reports, Indrad contributes ~80% of the company's US revenues (US is ~20% of total revenues). This, along with the fact that the Dahej unit (second most ANDAs filed after Indrad) is also under OAI is likely to affect future approvals. We expect minimal financial impact. In yet another incident, Glenmark's Baddi facility received a warning from USFDA. The inspection was conducted from April 15-20 earlier this year and was classified as official action indicated (OAI). As per the company, existing manufacturing & sale of products will not be impacted. Also, Baddi does not have any major pending approvals in the next 12 months. Expected sales from Baddi for FY20 are ~US$30 million (7% of US sales). We expect minimal financial impact on account of likely increase in remedial cost. Finally, the Indian pharmaceutical market (IPM) grew 11.9% YoY to | 12492 crore in September 2019. The growth was attributable to price hike: 5.6%, new product launches: 2.9% and volume growth: 3.5%. On a MAT basis, IPM growth was 9.8% YoY to | 136802 crore. Regulatory concern magnified; stock specific approach remains In the past few quarters, financially, things are looking much stable. The US generics narrative is reflecting some sort of normalcy on the back of a stability in base business performance and new launches besides rationalisation of unviable products. Domestic formulations are also showing a steady performance on an annual basis. Profitability is also likely to improve as the management commentary continues to suggest rationalisation of R&D and other related expenses, MR optimisation and concentrated focus on marketing costs for specialty and biosimilars. Waning concerns on Chinese raw material sourcing besides improving operating leverage are also likely to contribute to margin expansion. Similarly, the companies are moderating capex plans to focus on better RoCE. However, a sudden spurt in warning letters and OAIs even for players with hitherto unblemished cGMP record (read Torrent and Glenmark) have once again brought scepticism towards US focused generic players. In this backdrop, we continue to maintain our stock specific approach. India focused MNCs, CRAMs players and hospitals are our preferred picks in healthcare segment. Stock Performance Mcap Company 1M 3M YTD 1Y 10-Oct Sun Pharma.Inds. -10 -1 -10 -36 92876 Divi's Lab. 3 3 13 29 44360 Dr Reddy's Labs -4 2 1 6 43762 Cipla -11 -23 -19 -34 34035 Lupin -10 -9 -18 -19 31363 Biocon 3 -3 -24 -22 28848 Torrent Pharma. -2 9 -5 5 28535 Aurobindo Pharma -26 -22 -36 -40 27305 Cadila Health. -2 2 -33 -40 23751 Abbott 11 24 46 50 23358 Apollo Hospitals -6 7 12 26 19625 Pfizer -2 -3 9 15 14259 Sanofi -9 0 -10 -5 13155 Syngene Int. -4 -1 11 5 12398 Ipca Labs. -8 -10 7 38 10828 Fortis Health 11 9 0 7 10615 Alembic Pharma 8 3 -10 -10 10180 Natco Pharma -6 3 -19 -18 10001 Ajanta Pharma -4 7 -17 -7 8539 Glenmark Pharma -25 -35 -58 -52 8183 Jubilant Life -4 -2 -34 -30 7491 Narayana Hruday -5 5 21 -1 4812 Suven Life -7 0 11 -1 3204 FDC Ltd -1 -3 -5 -17 2843 Hikal -4 -13 -9 -13 1759 Hester Bio 1 -3 51 56 1446 Indoco Remedies -11 -7 -35 -24 1294 NGL Fine-Chem 7 3 19 6 320 Return (%) Source: Bloomberg Global Indices Performance Company 1M 3M YTD 1Y 3Y 5Y S&P 500 Pharm Inde 0 -6 1 -3 6 7 NASDAQ Biotechnol -5 -10 1 -12 1 3 S&P Pharmaceutica -6 -11 -5 -22 -7 -5 DJ Pharma and Biot -2 -7 1 -6 5 5 DJ STOXX Healthca 0 2 19 15 8 7 MSCI World Pharm 0 -3 6 0 6 5 NSE Pharma -10 -9 -18 -25 -14 -6 Return (%) Source: Bloomberg Research Analyst Siddhant Khandekar [email protected] MItesh Shah, CFA [email protected] Sudarshan Agarwal [email protected]

Health Check Glenmark Pharma. -25 -35 -58 -52 8183 -5 5 21 ...content.icicidirect.com/mailimages/IDirect_HealthCheck...Glenmark Pharma. -25 -35 -58 -52 8183 Jubilant Life -4 -2 -34

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  • ICIC

    I S

    ecurit

    ies –

    Retail E

    quit

    y R

    esearch

    Monthly

    Sector U

    pdate

    October 11, 2019

    Health Check

    Scepticism encircles generic players with flurry of

    cGMP issues

    In 2019, Indian companies received seven warning letters, ~10 Official

    Action Indicated (OAI) and a number of adverse observations from USFDA.

    In a recent update, Aurobindo Pharma’s Unit-7 has received Form 483 from

    USFDA with seven observations. The USFDA conducted cGMP related

    inspection at this unit from September 19-27, 2019. As per media reports,

    this plant is contributing 25-30% to US revenues. The company has ~33

    pending USFDA approvals as of Q1FY20 from Unit VII. We believe the

    observations are critical and the company is likely to face further remedial

    action from the USFDA like warning letter or in worst case scenario an

    import alert. We await further action from the USFDA. Although the

    company owns one of the best US generic ecosystem (lower product

    concentration- top 25 products account for just ~40% of US sales; growing

    non-oral franchise; number of alternate plants at the disposal; ~70% own

    API source), the overhang of a fourth plant coming under scrutiny within a

    span of few months is taking huge toll on the stock.

    In another cGMP related incident, Torrent's Indrad (Gujarat) facility received

    a warning letter from the USFDA. We were expecting this warning letter after

    it received OAI status from the USFDA in August 2019. The management

    expects no impact on existing supply and revenue generated from the

    facility. As per media reports, Indrad contributes ~80% of the company's US

    revenues (US is ~20% of total revenues). This, along with the fact that the

    Dahej unit (second most ANDAs filed after Indrad) is also under OAI is likely

    to affect future approvals. We expect minimal financial impact.

    In yet another incident, Glenmark's Baddi facility received a warning from

    USFDA. The inspection was conducted from April 15-20 earlier this year and

    was classified as official action indicated (OAI). As per the company, existing

    manufacturing & sale of products will not be impacted. Also, Baddi does not

    have any major pending approvals in the next 12 months. Expected sales

    from Baddi for FY20 are ~US$30 million (7% of US sales). We expect

    minimal financial impact on account of likely increase in remedial cost.

    Finally, the Indian pharmaceutical market (IPM) grew 11.9% YoY to | 12492

    crore in September 2019. The growth was attributable to price hike: 5.6%,

    new product launches: 2.9% and volume growth: 3.5%. On a MAT basis,

    IPM growth was 9.8% YoY to | 136802 crore.

    Regulatory concern magnified; stock specific approach remains

    In the past few quarters, financially, things are looking much stable. The US

    generics narrative is reflecting some sort of normalcy on the back of a

    stability in base business performance and new launches besides

    rationalisation of unviable products. Domestic formulations are also

    showing a steady performance on an annual basis. Profitability is also likely

    to improve as the management commentary continues to suggest

    rationalisation of R&D and other related expenses, MR optimisation and

    concentrated focus on marketing costs for specialty and biosimilars. Waning

    concerns on Chinese raw material sourcing besides improving operating

    leverage are also likely to contribute to margin expansion. Similarly, the

    companies are moderating capex plans to focus on better RoCE. However,

    a sudden spurt in warning letters and OAIs even for players with hitherto

    unblemished cGMP record (read Torrent and Glenmark) have once again

    brought scepticism towards US focused generic players. In this backdrop,

    we continue to maintain our stock specific approach. India focused MNCs,

    CRAMs players and hospitals are our preferred picks in healthcare segment.

    Stock Performance

    Mcap

    Company 1M 3M YTD 1Y 10-Oct

    Sun Pharma.Inds. -10 -1 -10 -36 92876

    Divi's Lab. 3 3 13 29 44360

    Dr Reddy's Labs -4 2 1 6 43762

    Cipla -11 -23 -19 -34 34035

    Lupin -10 -9 -18 -19 31363

    Biocon 3 -3 -24 -22 28848

    Torrent Pharma. -2 9 -5 5 28535

    Aurobindo Pharma -26 -22 -36 -40 27305

    Cadila Health. -2 2 -33 -40 23751

    Abbott 11 24 46 50 23358

    Apollo Hospitals -6 7 12 26 19625

    Pfizer -2 -3 9 15 14259

    Sanofi -9 0 -10 -5 13155

    Syngene Int. -4 -1 11 5 12398

    Ipca Labs. -8 -10 7 38 10828

    Fortis Health 11 9 0 7 10615

    Alembic Pharma 8 3 -10 -10 10180

    Natco Pharma -6 3 -19 -18 10001

    Ajanta Pharma -4 7 -17 -7 8539

    Glenmark Pharma. -25 -35 -58 -52 8183

    Jubilant Life -4 -2 -34 -30 7491

    Narayana Hrudayalaya-5 5 21 -1 4812

    Suven Life -7 0 11 -1 3204

    FDC Ltd -1 -3 -5 -17 2843

    Hikal -4 -13 -9 -13 1759

    Hester Bio 1 -3 51 56 1446

    Indoco Remedies -11 -7 -35 -24 1294

    NGL Fine-Chem 7 3 19 6 320

    Return (%)

    Source: Bloomberg

    Global Indices Performance

    Company 1M 3M YTD 1Y 3Y 5Y

    S&P 500 Pharm Index (US)0 -6 1 -3 6 7

    NASDAQ Biotechnology (US)-5 -10 1 -12 1 3

    S&P Pharmaceuticals (US)-6 -11 -5 -22 -7 -5

    DJ Pharma and Biotech (US)-2 -7 1 -6 5 5

    DJ STOXX Healthcare (EU)0 2 19 15 8 7

    MSCI World Pharm & Biotech0 -3 6 0 6 5

    NSE Pharma -10 -9 -18 -25 -14 -6

    Return (%)

    Source: Bloomberg

    Research Analyst

    Siddhant Khandekar

    [email protected]

    MItesh Shah, CFA

    [email protected]

    Sudarshan Agarwal

    [email protected]

  • ICICI Securities | Retail Research 2

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Exhibit 1: Warning Letters/OAIs issued to Indian companies

    in 2019

    Date Company Plant Status

    Mar-19 Lupin Somerset facility OAI

    Mar-19 Jubilant Life Roorkee Plant Warning Letter

    Apr-19 Lupin Unit 2, Pithampur OAI

    May-19 Aurobindo Unit I OAI

    May-19 Aurobindo Unit IX OAI

    May-19 Aurobindo Unit XI OAI

    May-19 Lupin Goa OAI

    Jun-19 Aurobindo Unit XI Warning Letter

    Jul-19 Torrent Dahej facility OAI

    Jul-19 Indoco Remedies Unit 1, Goa Warning Letter

    Jul-19 Strides Pharma Puducherry Plant Warning Letter

    Aug-19 Cadila Moraiya Plant OAI

    Aug-19 Torrent Indrad facility OAI

    Sep-19 Lupin Mandideep Plant Warning Letter

    Oct-19 Glenmark Baddi Plant Warning Letter

    Oct-19 Torrent Indrad facility Warning Letter

    Source: Company, ICICI Direct Research

  • ICICI Securities | Retail Research 3

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Healthcare Q2FY20 Results Preview

    One-offs, consolidations and base effect to drive Q2 numbers

    The I-direct healthcare universe is expected to register 16% YoY growth to

    | 34789 crore mainly due to one-offs (Lupin exclusivities in the US, Dr

    Reddy’s- sale of branded products) consolidations (Sun– Pola pharma,

    Aurobindo- Spectrum business, Cadila- Craft portfolio in wellness segment)

    and lower base. Domestic formulations (selected pack) are expected to grow

    14% YoY to | 5634 crore mainly due to inventory adjustment and lower base

    in Sun Pharma. Excluding the Sun base effect, domestic formulations are

    expected to grow at 8.4%. US (selected pack) is expected to grow 14% YoY

    to |10278 crore led by 1) growth in base business due to waning price

    erosion and lower base, 2) opportunities created by high profile exits and 3)

    new launches (including limited competition launches) besides

    consolidations. Europe is expected to grow 17% YoY. Growth in other

    emerging markets is likely to be driven by new launches. On the other hand,

    due to high base effect, the API segment is expected to decline 6% YoY. For

    Q2FY20, average YoY rupee depreciation vis-à-vis US$ was mere 0.4%. In

    case of Apollo Hospitals, growth is likely to be driven by newly

    commissioned hospitals and pharmacy additions.

    On the companies front, eight out of 10 companies are likely to report double

    digit growth. Among key outliers, Dr Reddy’s Labs (income from sale of

    branded portfolio), Biocon (biologics traction) and Cadila (consolidation of

    craft portfolio in wellness) are likely to register above 20% growth in

    revenues.

    EBITDA to grow 22% YoY; margins likely to expand 121 bps

    EBITDA of the I-direct healthcare universe is expected to grow 22.6% YoY

    to | 7706 crore. EBITDA margins are likely to improve 121 bps to 22.2% on

    the back of improved operational leverage, improvement in product mix and

    efficient cost control measures, thus mitigating higher raw material cost due

    to raw material supply constraints from China and higher promotional cost

    of specialty products.

    Net profit to grow 12% due to strong operational performance

    Net profit growth is expected to grow 12% YoY to | 4232 crore. A strong

    operational performance is likely to be offset partially by higher depreciation

    and financial cost.

    Exhibit 2: Estimates for Q2FY20 (| Crore)

    Revenue EBITDA PAT

    Q2FY20E YoY QoQ Q2FY20E YoY QoQ Q2FY20E YoY QoQ

    Aurobindo Pharma 5,588.4 17.6 2.6 1,168.3 18.5 1.5 683.0 7.0 5.3

    Biocon 1,618.3 22.5 10.4 446.1 31.4 2.0 208.0 25.4 0.8

    Cadila Healthcare 3,579.8 20.9 2.4 784.0 14.0 24.0 420.7 0.8 38.5

    Divi's Lab 1,351.4 5.2 16.2 487.9 -5.1 26.0 350.4 -11.9 28.6

    Dr. Reddys 4,587.1 20.2 18.9 1,222.0 60.9 61.2 790.0 52.4 14.1

    IPCA Labs 1,122.4 10.7 11.0 235.7 25.0 20.8 172.8 27.5 30.9

    Lupin 4,410.9 11.6 -0.2 816.0 48.5 -5.2 314.0 18.0 3.6

    Sunpharma 8,072.0 16 -3.6 1,655.8 8 -17.0 988.9 -1 -28.7

    Torrent Pharma 2,035.1 7.5 0.6 527.1 11.4 -2.6 201.6 12.6 -6.7

    Apollo Hospitals 2,423.4 15.9 8.7 362.9 40.7 11.4 102.9 30.3 29.7

    Total 34,788.6 15.9 3.9 7,705.7 22.6 5.8 4,232.4 11.6 -0.2

    Change (%) Change (%) Change (%)

    Company

    Source: Company, ICICI Direct Research

    Expected growth in domestic formulations

    (| cr) Q2FY20E Q2FY19 % Q1FY20 %

    Biocon 139 164 -15.0 133 4.8

    Cadila 956 893 7.0 948 0.9

    Ipca 534 469 14.0 453 18.0

    Lupin 1,348 1,203 12.0 1,308 3.0

    Dr Reddy's 789 686 15.0 696 13.4

    Sun Pharma2,351 1,860 26.4 2,314 1.6

    Torrent 864 816 5.9 907 -4.7

    Total 5634 4888 15.3 9381 -39.9

    Expected growth in US formulations

    (| cr) Q2FY20E Q2FY19 % Q1FY20 %

    Aurobindo 2,721 2,227 22.2 2,688 1.2

    Cadila 1,432 1,320 8.5 1,367 4.8

    Lupin 1,464 1,249 17.2 1,541 -5.0

    Dr Reddy's 1,673 1,427 17.3 1,632 2.5

    Sun Pharma2,615 2,401 8.9 2,947 -11.3

    Torrent 372 394 -5.6 376 -1.1

    Total 10278 9017 14.0 10552 -2.6

    Expected growth in Europe formulations

    (| cr) Q2FY20E Q2FY19 % Q1FY20 %

    Aurobindo 1,397 1,157 20.8 1,392 0.4

    Cadila 49 52 -5.0 47 4.2

    Dr Reddy's 239 192 25.0 240 -0.4

    Lupin 146 154 -5.0 140 4.0

    Torrent 276 251 10.0 262 5.4

    Total 2108 1805 16.8 2082 1.2

    Expected growth in API segment

    (| cr) Q2FY20E Q2FY19 % Q1FY20 %

    Aurobindo 735 817 -10.0 732 0.4

    Cadila 76 89 -15.0 69 9.3

    Divi's Lab 669 637 5.0 580 15.2

    Ipca Labs 256 225 13.9 298 -14.1

    Lupin 351 335 5.0 349 0.7

    Dr Reddy's 470 603 -22.0 454 3.6

    Sun Pharma 447 426 5.0 491 -8.8

    Total 2336 2494 -6.4 2393 -2.39

  • ICICI Securities | Retail Research 4

    ICICI Direct Research

    Monthly Sector Update | Health Check

    IPM grows ~12% YoY in September, price led growth again…

    The Indian pharmaceutical market (IPM) grew 11.9% YoY to | 12492 crore

    in September 2019. The growth was attributable to price hike: 5.6%, new

    product launches: 2.9% and volume growth: 3.5%.

    Drugs under NLEM list grew 13.2% YoY & non-NLEM drugs grew 11.8 %.

    The fixed dosage combination (FDCs) related market showed a decline of

    66.5% while the approved FDC market grew 12.3%.

    Among companies under I-direct coverage 8 companies (Dr Reddy’s, FDC,

    Lupin, Torrent, Abbott, Glenmark, Indoco, and Sun Pharma) have

    outperformed industry growth rate.

    Therapy wise, nine major therapies have registered faster than industry

    growth. Notable among them with growth rates- vaccines - 20.5%,

    stomatologicals – 19.1%, urology – 18.6%, anti-diabetic -14.2%, cardiac –

    13.7%, pain – 12.6% and GI – 12.1%.

    Domestic companies have grown at 11.6% YoY while MNC companies have

    grown at 13.5%.

    On a MAT basis, IPM growth was 9.8% YoY to | 136802 crore.

    Exhibit 3: Domestic formulations - growth trend

    Source: ICICI Direct Research; AIOCD

    Exhibit 4: Companies growth in domestic market in September 2019

    Source: ICICI Direct Research, AIOCD

    7.2

    12.4

    7.0

    9.7

    10.8

    9.8

    8.8

    10.4

    7.1

    6.7

    13.2

    9.5

    11.9

    0.0

    5.0

    10.0

    15.0

    Sep-18

    Oct-18

    Nov-18

    Dec-18

    Jan-19

    Feb-19

    Mar-19

    Apr-19

    May-19

    Jun-19

    Jul-19

    Aug-19

    Sep-19

    (%

    )

    Indian Pharma Market

    13.9

    5.7

    0.2

    7.6

    11.8

    5.9

    24.022.9

    9.3

    13.9

    9.2

    19.3

    5.2

    9.4

    11.4

    12.9

    17.5

    0.0

    5.0

    10.0

    15.0

    20.0

    25.0

    30.0

    Abbott

    Aja

    nta

    Ale

    mbic

    Bio

    con

    Cadila

    Cip

    la

    DR

    L

    Gle

    nm

    ark

    GS

    K P

    harm

    a

    Indoco

    Ipca L

    abs

    Lupin

    Natco

    Pfiz

    er

    Sanofi

    Sun P

    harm

    a

    Torrent

    (%

    )

    Therapy wise performance (| crore)

    Therapy Sep'19 Sep'18 %Aug'19 %

    Anti-Infectives 1898 1712 10.9 1806 5.1

    Cardiac 1473 1296 13.7 1463 0.7

    GI 1408 1257 12.1 1423 -1.1

    Anti Diabetic 1147 1004 14.2 1164 -1.5

    Vitamins 1076 966 11.4 1079 -0.2

    Respiratory 946 877 7.8 872 8.5

    Pain 874 776 12.6 866 0.9

    Derma 829 751 10.3 813 2.0

    Neuro 721 645 11.9 715 0.8

    Gynaecological 586 543 7.9 585 0.2

    Anti-Neoplastics 255 230 11.2 245 4.1

    Hormones 225 201 11.8 219 2.5

    Ophthal 219 197 10.8 219 -0.1

    Vaccines 192 159 20.5 187 2.5

    Urology 167 140 18.6 163 2.4

    Blood Related 158 135 17.1 148 7.4

    Others 117 99 18.2 112 4.8

    Anti Malarials 75 67 11.2 62 20.0

    Stomatologicals 65 55 19.1 65 0.5

    Sex Stimulants 61 50 21.8 62 -1.5

    Top brands in Indian pharma market (MAT;

    | crore)

    Source: ICICI Direct Research; AIOCD

    Source: ICICI Direct Research; AIOCD

    Acute vs Chronic vs Sub Chronic

    Source: ICICI Direct Research; AIOCD; As per AIOCD MAT Sep 2019

    Acute

    47%

    Chronic

    33%

    Sub

    Chronic

    20%

    Brand Company Therapy Sep'19YoY %

    Mixtard Abbott Anti Diabetic 539 8.4

    Lantus Sanofi IndiaAnti Diabetic 499 18.4

    Galvus Met Novartis Anti Diabetic 483 10.3

    Glycomet GpUSV Anti Diabetic 474 15.8

    Janumet MSD Anti Diabetic 469 16.0

    Augmentin GSK Anti-Infectives429 18.2

    Liv 52 Himalaya GI 397 4.7

    Duphaston Abbott Hormones 388 26.0

    Clavam Alkem Anti-Infectives370 14.7

    Thyronorm Abbott Hormones 352 11.9

  • ICICI Securities | Retail Research 5

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Exhibit 3: Domestic formulations – Market Share (MAT Value September 2019)

    Source: ICICI Direct Research; AIOCD

    Exhibit 4: Acute vs. Chronic vs. sub chronic (MAT Value September 2019)

    Source: ICICI Direct Research; AIOCD

    8%

    6%

    5%

    4%4%

    3%

    2% 2% 2% 2%

    1%1%

    1% 1% 1% 1%0%

    0%

    1%

    2%

    3%

    4%

    5%

    6%

    7%

    8%

    9%

    Sun

    Abbott

    Cip

    la

    Cadila

    Lupin

    Torrent

    Pfiz

    er

    Dr.

    Reddys

    Sanofi

    Gle

    nm

    ark

    Ipca

    Ale

    mbic

    FD

    C

    Natco

    Indoco

    Aja

    nta

    Bio

    con

    38 39

    57

    3242

    52

    77

    40

    82

    65

    27

    88

    41

    62

    44 40

    26

    54

    4051

    2460

    45 29

    9

    41

    527

    57

    0

    55 15 5245

    52

    31

    2210

    209 13

    2013 19

    13 7 16 114

    23

    415

    21 16

    0

    20

    40

    60

    80

    100

    120

    Abbott

    Aja

    nta

    Ale

    mbic

    Bio

    con

    Cip

    la

    Dr.

    Reddys

    FD

    C

    Gle

    nm

    ark

    Indoco

    IPC

    A

    Lupin

    Sun

    Novartis

    Pfiz

    er*

    Sanofi

    Sun

    Torrent

    Cadila

    %

    Acute Chronic Sub Chronic

  • ICICI Securities | Retail Research 6

    ICICI Direct Research

    Monthly Sector Update | Health Check

    IPM grows ~12% YoY in Q2FY20, price led growth…

    The Indian pharmaceutical market (IPM) grew 11.5% YoY to | 36725 crore

    in Q2FY20. The growth was attributable to price hike: 5.5%, new product

    launches: 2.8% and volumes growth: 3.2%

    The fixed dosage combination (FDCs) related market showed a decline of

    67.0% while the approved FDC market grew 12.2% and single product

    market grew 11.9%.

    Drugs under NLEM list grew 13.5% YoY while non-NLEM drugs grew 11.4%.

    Growth was mainly driven by price hikes.

    Among companies under I-direct coverage 8 companies (Dr Reddy’s, Lupin,

    FDC, Indoco, Abbott, Cadila, Sanofi, Torrent) have outperformed industry

    growth rate.

    Therapy wise, 12 major therapies have registered faster than industry

    growth. Notable among them with growth rates- anti-malarials -18%,

    stomatologicals -17.1%, urology -17%, vaccines – 14.1%, anti-infectives –

    14%, sex-stimulants – 13.7%, anti-diabetic – 13.5%, respiratory – 12.4%,

    pain – 12.2%, hormones -11.6%.

    Domestic companies have grown at 11.3% YoY while MNC companies have

    grown at 12.6%

    Exhibit 5: Domestic formulations - growth trend

    Source: ICICI Direct Research; AIOCD

    Exhibit 6: Companies growth in domestic market in Q2FY20

    Source: ICICI Direct Research, AIOCD

    0.1

    7.0 7.1 7.3

    1.9 2.3 2.5

    0.1

    3.2

    -2.1 -1.6-1.1 -0.9

    5.0 4.94.9

    5.1

    5.5

    2.7

    2.7

    2.7 2.7 2.7 2.7 2.5

    2.9

    2.8

    0.7

    6.4

    8.6 9.0 9.79.8 9.9

    8.1

    11.5

    -4.0

    -2.0

    0.0

    2.0

    4.0

    6.0

    8.0

    10.0

    12.0

    14.0

    2QFY18 3QFY18 4QFY18 1QFY19 2QFY19 3QFY19 4QFY19 1QFY20 2QFY20

    Volumes Price Increases New Products

    12.3

    5.8

    2.5

    8.1 7.6

    19.3

    16.9

    8.2

    16.6

    10.2

    16.9

    (3.2)

    7.8

    14.1

    11.4 12.7

    13.7

    (5.0)

    -

    5.0

    10.0

    15.0

    20.0

    25.0

    Abbott

    Aja

    nta

    Ale

    mbic

    Bio

    con

    Cip

    la

    Dr.

    Reddys L

    ab

    FD

    C

    Gle

    nm

    ark

    Indoco

    IPC

    A

    Lupin

    Natco

    Pfiz

    er

    Sanofi

    Sun

    Torrent

    Cadila

    (%

    )

    Therapy wise performance (| crore)

    Therapy Q2FY20 Q2FY19 %Q1FY20 %

    Anti-Infectives5303 4653 14.0 4128 28.4

    Cardiac 4418 3960 11.5 4331 2.0

    GI 4251 3833 10.9 3983 6.7

    Anti Diabetic 3488 3074 13.5 3374 3.4

    Vitamins 3249 2943 10.4 3046 6.6

    Respiratory 2585 2299 12.5 2112 22.4

    Pain 2562 2284 12.2 2279 12.4

    Derma 2451 2266 8.2 2245 9.2

    Neuro 2151 1953 10.2 2076 3.6

    Gynaecological1772 1663 6.5 1756 0.9

    Anti-Neoplastics749 713 5.1 757 -1.0

    Hormones 661 592 11.6 613 7.7

    Ophthal 659 599 10.0 650 1.4

    Vaccines 573 502 14.1 527 8.7

    Urology 494 422 17.0 474 4.2

    Blood Related 456 392 16.2 414 10.1

    Others 340 300 13.1 318 7.0

    Anti Malarials 195 165 18.0 183 6.1

    Stomatologicals187 159 17.1 193 -3.3

    Sex Stimulants 183 161 13.7 105 75.1

    Source: ICICI Direct Research; AIOCD

  • ICICI Securities | Retail Research 7

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Exhibit 7: Top five brands in value terms (MAT Value September 2019)

    Sun Brand Therapy Sales

    1 Rosuvas Cardiac 269

    2 Levipil Neuro 266

    3 Istamet Anti Diabetic 259

    4 Volini Pain 251

    5 Gemer Anti Diabetic 200

    Cipla Brand Therapy Sales

    1 Foracort Respiratory 324

    2 Budecort Respiratory 226

    3 Duolin Respiratory 214

    4 Seroflo Respiratory 191

    5 Asthalin Respiratory 167

    Cadila Brand Therapy Sales

    1 Skinlite Derma 170

    2 Deriphyllin Respiratory 161

    3 Atorva Cardiac 133

    4 Pantodac GI 121

    5 Mifegest Kit Gynaecological 120

    Lupin Brand Therapy Sales

    1 Gluconorm-G Anti Diabetic 253

    2 Huminsulin Anti Diabetic 186

    3 Budamate Respiratory 124

    4 Gibtulio Anti Diabetic 122

    5 Ondero Anti Diabetic 106

    Torrent Brand Therapy Sales

    1 Shelcal Vitamins 219

    2 Chymoral FortePain 152

    3 Nikoran Cardiac 107

    4 Azulix-Mf Anti Diabetic 101

    5 Losar H Cardiac 97

    Dr. Reddys Brand Therapy Sales

    1 Omez GI 142

    2 Omez D GI 125

    3 Econorm GI 124

    4 Atarax Derma 102

    5 Razo D GI 84

    Glenmark Brand Therapy Sales

    1 Telma Cardiac 258

    2 Telma H Cardiac 205

    3 Telma Am Cardiac 132

    4 Candid Derma 117

    5 Ascoril Plus Respiratory 109

    IPCA Brand Therapy Sales

    1 Zerodol Sp Pain 189

    2 Zerodol P Pain 122

    3 Hcqs Anti Malarials 113

    4 Folitrax Anti-Neoplastics 63

    5 Glycinorm M Anti Diabetic 51

    Alembic Brand Therapy Sales

    1 Azithral Anti-Infectives 162

    2 Althrocin Anti-Infectives 80

    3 Wikoryl Respiratory 70

    4 Roxid Anti-Infectives 53

    5 Gestofit Gynaecological 49

    Natco Brand Therapy Sales

    1 Velpanat Anti-Infectives 190

    2 Hepcinat Anti-Infectives 160

    3 Geftinat Anti-Neoplastics 122

    4 Erlonat Anti-Neoplastics 104

    5 Natdac Anti-Infectives 94

    Indoco Brand Therapy Sales

    1 Febrex Plus Respiratory 87

    2 Cyclopam GI 55

    3 Sensodent-K Stomatologicals 51

    4 Oxipod Anti-Infectives 50

    5 Atm Anti-Infectives 46

    Ajanta Brand Therapy Sales

    1 Met Xl Cardiac 106

    2 Atorfit Cv Cardiac 55

    3 Melacare Derma 50

    4 Feburic Pain 34

    5 Met Xl Am Cardiac 26

    Biocon Brand Therapy Sales

    1 Insugen Anti Diabetic 114

    2 Basalog Anti Diabetic 87

    3 Canmab Anti-Neoplastics 80

    4 Insugen R Anti Diabetic 25

    5 Erypro Blood Related 22

    Abbott Brand Therapy Sales

    1 Mixtard Anti Diabetic 539

    2 Duphaston Gynaecological 388

    3 Thyronorm Hormones 352

    4 Novomix Anti Diabetic 308

    5 Phensedyl Cough LinctusRespiratory 288

    Sanofi Brand Therapy Sales

    1 Lantus Anti Diabetic 499

    2 Allegra Respiratory 187

    3 Combiflam Pain 183

    4 Amaryl M Anti Diabetic 160

    5 Hexaxim Vaccines 155

    Source: ICICI Direct Research; AIOCD; Sanofi includes Sanofi India and Sanofi Pasteur (Vaccine)

  • ICICI Securities | Retail Research 8

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Exhibit 8: Top five therapies in value term (MAT value September 2019)

    Sun Therapy Sales (|cr)

    1 Cardiac 1980

    2 Neuro 1882

    3 GI 1348

    4 Anti-Infectives 1126

    5 Anti Diabetic 1036

    Cipla Therapy Sales (|cr)

    1 Respiratory 2186

    2 Anti-Infectives 1355

    3 Cardiac 842

    4 GI 464

    5 Urology 369

    Cadila Therapy Sales (|cr)

    1 Anti-Infectives 866

    2 Cardiac 777

    3 GI 608

    4 Respiratory 618

    5 Pain 537

    Lupin Therapy Sales (|cr)

    1 Cardiac 1239

    2 Anti Diabetic 1225

    3 Anti-Infectives 744

    4 Respiratory 637

    5 GI 378

    Torrent Therapy Sales (|cr)

    1 Cardiac 1297

    2 GI 672

    3 Neuro 624

    4 Vitamins 535

    5 Anti Diabetic 341

    Dr. Reddys Therapy Sales (|cr)

    1 GI 725

    2 Cardiac 428

    3 Derma 343

    4 Anti-Infectives 218

    5 Respiratory 257

    Glenmark Therapy Sales (|cr)

    1 Derma 860

    2 Cardiac 834

    3 Respiratory 528

    4 Anti-Infectives 379

    5 Anti Diabetic 265

    IPCA Therapy Sales (|cr)

    1 Pain 564

    2 Cardiac 324

    3 Anti Malarials 296

    4 GI 134

    5 Anti-Infectives 135

    Alembic Therapy Sales (|cr)

    1 Anti-Infectives 360

    2 Cardiac 258

    3 Respiratory 216

    4 GI 200

    5 Gynaecological 192

    Natco Therapy Sales (|cr)

    1 Anti-Neoplastics 516

    2 Anti-Infectives 535

    3 Pain 33

    4 Cardiac 4

    5 Blood Related 2

    Indoco Therapy Sales (|cr)

    1 Respiratory 157

    2 Anti-Infectives 155

    3 Stomatologicals 164

    4 GI 126

    5 Vitamins 72

    Ajanta Therapy Sales (|cr)

    1 Cardiac 345

    2 Ophthal 195

    3 Derma 132

    4 Pain 47

    5 Vitamins 29

    Biocon Therapy Sales (|cr)

    1 Anti Diabetic 261

    2 Anti-Neoplastics 138

    3 Anti-Infectives 22

    4 Cardiac 10

    5 Blood Related 24

    Abbott Therapy Sales (|cr)

    1 Anti Diabetic 1709

    2 GI 1452

    3 Vitamins 893

    4 Neuro 722

    5 Cardiac 638

    Sanofi Therapy Sales (|cr)

    1 Anti Diabetic 942

    2 Cardiac 486

    3 Vaccines 398

    4 Respiratory 321

    5 Pain 268

    Source: ICICI Direct Research, AIOCD; Sanofi includes Sanofi India and Sanofi Pasteur (Vaccine)

  • ICICI Securities | Retail Research 9

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Monthly Sector News

    Price hikes, new launches, recalls, approvals

    Glenmark receives Orphan Drug Designation for its antibody candidate

    Glenmark receives Orphan Drug Designation from USFDA for GBR 1342, a

    bispecific antibody candidate under evaluation for the treatment of Multiple

    Myeloma

    Torrent Pharma expands Losartan recall in US

    As per USFDA, Torrent Pharma has expanded recall of its hypertension

    drugs, Losartan potassium tablets & Losartan

    potassium/hydrochlorothiazide tablets in US due to detection of trace of N-

    Methylnitrosobutyric, a known animal & potential human carcinogen

    Dr Reddy's wins bid under China's pilot programme

    As per a Chinese media report, Dr Reddy’s has won a bid for supplying

    Olanzapine, an antipsychotic used to treat schizophrenia & bipolar disorder.

    The company had offered a 35 % price cut under China’s drug procurement

    pilot program to secure the bid. The drug will be supplied to public hospitals

    in several provinces of China including Zhejiang, Hunan and Guangxi

    GSK Pharma recalls Ranitidine drug in India, halts global supply

    GSK pharma has suspended supply and distribution of its ranitidine

    hydrochloride (Zinetac) products worldwide due to regulatory concerns into

    presence of genotoxic nitrosamine NDMA in the drug. The company has

    also issued a voluntary recall of Zinetac Tablets in India.

    Biocon plans 70% cut in insulin prices

    As per media reports, Biocon plans to bring down the cost of insulin to US$

    0.10 (~| 7) in low & middle income countries. Currently blended median

    patient prices are US$ 9 per 10ml vial (~US$ 0.36 per day for 40 units)

    Biocon launches insulin biosimilar in Australia

    Biocon and Mylan N.V. have launched the first insulin Glargine biosimilar

    (Semglee, 3mL pre-filled pen) for injection, 100 IU/mL available on the

    Pharmaceuticals Benefit Scheme in Australia

    Dr Reddy’s suspends its Ranitidine supply worldwide

    As per media reports, Dr Reddy’s has suspended supply of its OTC drug

    Ranitidine (GI therapy) worldwide, as a precautionary measure due to

    USFDA probe into reported presence of impurity N-

    nitrosodimethylamine(NDMA) at low levels.

    Lawsuits, court rulings, settlements, regulatory issues

    USFDA inspects Glenmark’s Indore Unit

    As per media reports, Glenmark's Indore unit did not receive any

    observations from the USFDA after the cGMP inspection conducted from

    September 9-13, 2019

    Cipla’s Pithampur facilities get GMP certificate from UK MHRA

    As per media reports, Cipla's manufacturing facilities in Pithampur, Madhya

    Pradesh(unit I/II/IV) has gotten UK MHRA’s GMP certification for the

    inspection conducted on June 04, 2019

    Lupin receives warning letter from USFDA

    Lupin’s Mandideep (Unit-1) facility in Madhya Pradesh has received a

    warning letter from the USFDA. This plant manufactures cephalosporin API

    and formulations. The warning letter follows an inspection of the plant in

    Dec’18 and its classification as OAI (official action indicated) in Mar’19.

    Cipla’s Bengaluru API facility receives EIR from USFDA

    Inspection of Cipla's API manufacturing facility at Virgonagar, Bengaluru has

    been closed with receipt of establishment inspection report (EIR) from

  • ICICI Securities | Retail Research 10

    ICICI Direct Research

    Monthly Sector Update | Health Check

    USFDA. The facility had received seven observations after the cGMP

    inspection conducted from July 15-19, 2019

    Biocon’s new Bengaluru facilities receives Form 483 from USFDA

    USFDA conducted pre-approval Inspection at two of Biocon’s new Biologics

    Manufacturing facilities in Bengaluru from Sep 10-19, 2019. The inspection

    included a new Drug Substance (DS) and a Drug Product (DP) unit. At the

    end of inspection, USFDA issued a Form 483 with four observations for the

    new DS facility, three observations for the new DP facility and one general

    observation

    USFDA inspects Lupin’s Tarapur Unit

    Lupin’s API facility at Tarapur receives three observations from USFDA after

    the inspection carried out from September 16-20, 2019

    Cadila’s API unit at Ankaleshwar receives NAI status from USFDA

    Cadila’s API manufacturing facility at Ankaleshwar, Gujarat has received EIR

    from USFDA classifying it as ‘No Action Indicated’ (NAI), indicating clearance

    of plant. The inspection was conducted by USFDA from July 22-26, 2019

    USFDA completes inspection of Alembic’s Gujarat formulation facility

    Alembic Pharma’s (Aleor Derma JV) formulation manufacturing facility at

    Karkhadi, Gujarat has received one observation at the end of USFDA

    inspection carried out from September 16-20, 2019

    Sebi imposes | 22.7 crore fine on Aurobindo Pharma for insider trading

    As per media reports, SEBI has imposed a penalty of | 22.7 crore on

    Aurobindo Pharma, it's promoters & related entities for violation of insider

    trading norms in relation to a licensing deal it entered into with Pfizer in 2009.

    The regulator had investigated trading in the company's scrip based on

    unpublished price sensitive information (UPSI) from July 2008 to March

    2009

    Cipla gets Form 483 after USFDA inspection

    Cipla's Goa manufacturing facility has received Form 483 with 12

    observations from USFDA after the cGMP inspection conducted from

    September 16-27

    Lupin's Goa facility completes Japan's PMDA inspection

    Lupin's Goa facility (Unit - I & II) has completed GMP inspection by

    Pharmaceutical and Medical Devices Agency (PMDA), Japan. As per the

    company, no critical or major observations were issued after the inspection

    that was conducted from September 24-27, 2019

    Glenmark receives Russian MoH approval to market rhinitis drug

    Glenmark Pharma has received approval from the Russian Ministry of

    Healthcare to market Montlezir (Levocetirizine Dihydrochloride 5mg +

    Montelukast Sodium 10mg) film‐coated tablets as a prescription product. The drug is indicated for the treatment of seasonal and perennial allergic

    rhinitis. It is expected to be available in the Russian market by Q3 FY19‐20

    Natco’s API facility at Mekaguda receives EIR from USFDA

    Natco Pharma has received an establishment inspection report (EIR) from

    USFDA indicating closure of inspection for its API facility at Mekaguda

    Village near Hyderabad. The inspection was conducted from 5-9 August,

    2019 at the end of which the facility had received a Form 483 with six

    observations

    Dr Reddy’s API facility receives EIR from USFDA

    Dr Reddy's API facility at Bollaram, Hyderabad (Plant 2) has received an

    establishment inspection report (EIR) from USFDA indicating audit closure.

  • ICICI Securities | Retail Research 11

    ICICI Direct Research

    Monthly Sector Update | Health Check

    The facility, now classified as voluntary action indicated (VAI), had earlier in

    July received a Form 483 with five observations

    USFDA issues warning letter to Glenmark's Baddi facility

    USFDA issued a warning letter to Glenmark's Baddi facility in Himachal

    Pradesh. The inspection was conducted from April 15-20 earlier this year

    and was classified as official action indicated (OAI). As per the company,

    existing manufacturing & sale of products will not be impacted and there are

    no major pending approvals from Baddi in the next 12 months. The Baddi

    facility's expected sales for FY20 are ~US$30 million (7% of US sales).

    We do not expect any material impact on the company's financials, except

    a likely increase in remedial cost. However, stock is likely to remain under

    pressure in near term due to this amendment

    Aurobindo's Unit VII receives seven USFDA observations

    The company's Unit-7 has received Form 483 from USFDA with seven

    observations. The USFDA conducted cGMP related inspection at this unit

    from September 19-27, 2019. As per the management, none of the

    observations are related to data integrity. It is confident of addressing these

    issues within the stipulated timeline

    Unit VII is one of the largest and oldest plants for the company. As per media

    reports, this plant is contributing 25-30% to US revenues. The company has

    ~33 pending USFDA approvals (including 14 tentative approvals) by the end

    of Q1FY20 from Unit VII. We believe the observations are critical and the

    company is likely to face further remedial action from the USFDA like

    warning letter or in worst case scenario an import alert. We await further

    action from USFDA. Until then, we believe the stock is likely to remain under

    pressure

    Lupin's Mandideep facility receives GMP certificate from Japan's PMDA

    Lupin's Mandideep API facility (Unit - II) has received GMP certificate from

    Pharmaceutical and Medical Devices Agency (PMDA), Japan. As per the

    company, no critical or major observations were issued after the inspection

    that was conducted from May 14-17, 2019

    Torrent's Gujarat Indrad facility receives warning letter from USFDA.

    Torrent's Gujarat Indrad facility receives warning letter from USFDA. Earlier

    in August 2019 the US regulator had classified the facility (API &

    Formulations) as official action indicated (OAI) after the inspection in April.

    M&As, demergers, tie-ups and JVs

    Cipla, Stempeutics sign agreement for novel stem cell product

    As per media reports, Stempeutics Research signs an out-licensing deal with

    Cipla for novel stem cell product 'Stempeucel-DFU' for treatment of non-

    healing diabetic foot ulcer. As per the agreement Cipla will get marketing

    rights for 5 years in India while Stempeutics will supply and manufacture the

    product

    CCI approves restructuring of Apollo’s Pharmacy business

    CCI has approved restructuring & sale of Apollo Hospitals’ (AHEL) Pharma

    business. This will help AHEL bring down its net debt. After the exercise

    AHEL will hold 25.5% stake in Apollo Pharmacy Ltd

    Biocon expands its R&D footprint through acquisition

    Biocon acquired a 60,000 sq ft biologics R&D facility at TICEL bio-park in

    Chennai from Pfizer Healthcare.

    Apollo Hospitals to set up JV with Wellysis

    As per media reports, Apollo Hospitals (AHEL) has launched a cardiac

    command centre with connected technologies like tele-ECG monitoring,

    tele-ECHO monitoring and remote Cathlab. AHEL has also signed an MoU

  • ICICI Securities | Retail Research 12

    ICICI Direct Research

    Monthly Sector Update | Health Check

    with Wellysis (Samsung SDS South Korea spin-off) to set up a JV in Chittoor,

    Andhra Pradesh. The JV will develop, manufacture and commercialize

    cardiac wellness, diagnostics, monitoring and therapeutic devices.

    Lupin completes sale of its subsidiary in Japan, Kyowa CritiCare

    Lupin has completed the sale of Kyowa CritiCare's injectables business and

    related assets to the Neopharma Group.

    Cadila to sell its cholesterol lowering drug rights in US & Canada

    Cadila Healthcare has signed an agreement to sell rights of its cholesterol

    lowering Zypitamag (pitavastatin) to Medicure Inc for US & Canada markets.

    Under terms of the agreement, Cadila will receive an upfront payment of

    US$ 5 million and US$2 million in deferred payments over the next four

    years along with sales milestone contingent payments & royalties.

    Biocon, Evotec enter strategic deal for an early stage biosimilar

    Biocon biologics, Just-Evotec ink pact for an early stage, pre-clinical

    biosimilar asset. Biocon through this strategic in-licensing agreement will

    expand its therapy basket & assume all development, manufacture &

    commercialization for the asset. Evotec will receive milestone payments in

    addition to the license fee.

    Others

    Apollo Hospitals launches AI-enabled Health Risk Assessment program

    As per media sources, Apollo Hospitals has launched an AI-enabled

    personalised Health Risk Assessment program 'Apollo Prohealth'. It has

    been introduced in Chennai & Hyderabad, and will be extended to other

    cities.

    Apollo Hospitals’ promoter releases pledge shares

    Apollo Hospitals’ promoter has released pledge on 79.4 lakh shares (5.7%

    share capital) on Sept 19-20 by repaying debt obligations

    Cadila announces positive clinical trial results from investigational molecule

    Cadila healthcare has announced positive results from clinical trials

    (EVIDENCES IV) of Saroglitazar Magnesium, for treatment of non-alcoholic

    fatty liver disease (NAFLD) and non-alcoholic Steatohepatitis (NASH)

    Sun Pharma presents positive trial results from ILUMYA

    Sun Pharma presents results of long-term Phase 3 trials for ILUMYA

    (tildrakizumab-asmn) showing significant skin clearance, maintained over

    four years in people with moderate to severe plaque psoriasis at the 28th

    European Academy of Dermatology and Venereology Congress (EADV) in

    Madrid, Spain

    ANDA Approvals

    Lupin has received sANDA approval for generic version of Unithroid

    (Levothyroxine Sodium) Tablets, 25/50/75/88/100/112/125/137

    /150/175/200/300 mcg. The drug is used in treatment of hypothyroidism &

    for Pituitary Thyrotropin Suppression. The drug(Unithroid & Synthroid) had

    annual sales of ~US$2581 million in the US(IQVIA MAT June 2019).

    Cipla has launched the generic version of Cubicin (Daptomycin, antibiotic)

    single-dose 500mg/vial for injection in US. This drug had an annual sales of

    ~US$606 million in the US (IQVIA MAT June 2019).

    Cadila gets USFDA approval for the generic version of Clobex (Clobetasol

    Propionate, Therapy - derma) Lotion, 0.05% in US.

    Lupin has launched the generic version of Pfizer’s Viagra (Sildenafil) Tablets,

    25/50/100 mg in US. The drug, used for treatment of erectile dysfunction,

    had an annual sales of ~US$ 216 million in US as per IQVIA MAT July 2019.

    Lupin gets USFDA approval for the generic version of Pfizer’s Dilantin

    (Extended Phenytoin Sodium, CNS therapy) Capsules, 100 mg. The drug,

  • ICICI Securities | Retail Research 13

    ICICI Direct Research

    Monthly Sector Update | Health Check

    indicated for treatment & prevention of seizures, had annual sales of ~US$

    105 million in US as per IQVIA MAT June 2019.

    Alembic Pharma (Aleor Derma, JV) gets USFDA approval for generic version

    of Galderma's Clobex (Clobetasol Propionate, Therapy - derma) Spray,

    0.05% in US. The drug, used in treatment of moderate to severe plaque

    psoriasis, had an estimated market size of ~US$ 22 million in US as per

    IQVIA MAT December 2018.

    Lupin has launched the generic version of Roche's immunosuppressant

    Cellcept (Mycophenolate Mofetil) capsules, 250mg in US. The drug, used for

    prophylaxis of organ rejection during transplants, had annual sales of ~

    US$53 million in the US (IQVIA MAT August 2019).

    Glenmark has received tentative ANDA approval from USFDA for the

    generic version of Biogen's Tecfidera (Dimethyl Fumarate, CNS therapy)

    delay-released Capsules, 120/240 mg. The drug, used to treat relapsing

    multiple sclerosis (MS), had annual sales of ~US$ 3.7 billion in US as per

    IQVIA MAT August 2019.

    Cadila Healthcare has received final USFDA approval to market cholesterol

    lowering Colesevelam Hydrochloride (RLD – Welchol) Tablets, 625mg in US.

    The drug will be manufactured at the formulations facility at SEZ,

    Ahmedabad.

    Exhibit 9: One Year forward PE

    Source: ICICI Direct Research, Bloomberg

    0.0

    10.0

    20.0

    30.0

    40.0

    Sep-16

    Mar-17

    Sep-17

    Mar-18

    Sep-18

    Mar-19

    Sep-19

    x

    NSE500 Index NSE Pharma

    42% Premium

  • ICICI Securities | Retail Research 14

    ICICI Direct Research

    Monthly Sector Update | Health Check

    Exhibit 10: ICICI Direct coverage Universe (Healthcare)

    Company I-Direct CMP TP Rating M Cap

    Code (|) (|) (| cr) FY18 FY19 FY20E FY21E FY18 FY19 FY20E FY21E FY18 FY19 FY20E FY21E FY18 FY19FY20EFY21E

    Ajanta Pharma AJAPHA 977 1,010 Hold 8522 53.0 43.5 47.5 60.2 18.4 22.4 20.6 16.2 30.0 21.8 20.8 22.4 23.0 17.1 16.4 18.0

    Alembic PharmaALEMPHA 542 560 Hold 10226 21.9 31.4 29.9 24.7 24.8 17.3 18.1 22.0 18.0 19.6 17.5 15.8 18.6 21.7 17.1 14.2

    Apollo HospitalsAPOHOS 1407 1,500 Buy 19576 8.5 17.7 25.7 39.1 166.4 79.6 54.7 36.0 6.3 8.8 11.1 14.0 3.6 7.4 9.9 13.4

    Aurobindo PharmaAURPHA 464 735 Buy 27173 41.6 42.1 49.1 61.2 11.1 11.0 9.5 7.6 20.0 15.9 14.3 16.3 20.7 17.7 17.3 18.0

    Biocon BIOCON 240 330 Buy 28746 3.1 6.2 8.2 9.1 77.2 38.6 29.3 26.3 8.1 10.9 13.4 16.1 7.2 12.2 13.4 15.2

    Cadila HealthcareCADHEA 232 250 Hold 23751 17.5 18.1 13.7 17.9 13.2 12.8 16.9 12.9 16.7 13.0 10.6 12.7 20.5 17.8 12.2 14.2

    Cipla CIPLA 422 520 Hold 33987 18.3 18.6 21.4 25.9 23.0 22.7 19.7 16.3 9.6 10.9 12.4 13.7 10.4 10.0 10.5 11.5

    Divi's Lab DIVLAB 1665 1,640 Hold 44201 33.3 51.0 50.3 63.1 50.0 32.7 33.1 26.4 20.0 25.5 21.7 23.3 14.9 19.4 16.8 17.9

    Dr Reddy's LabsDRREDD 2643 2,770 Hold 43890 57.0 114.8 163.4 157.7 46.3 23.0 16.2 16.8 6.1 11.1 16.1 15.6 7.2 13.6 16.6 14.2

    Glenmark PharmaGLEPHA 291 410 Hold 8197 28.5 26.9 28.3 34.2 10.2 10.8 10.3 8.5 14.6 14.5 13.5 14.5 15.6 13.5 12.6 13.3

    Hikal HIKCHE 143 205 Buy 2022 6.3 8.4 10.1 13.6 22.8 17.1 14.1 10.5 12.2 14.3 14.8 17.2 11.5 13.6 14.5 16.5

    Ipca Laboratories IPCLAB 858 1,195 Buy 10840 19.0 35.1 47.5 59.7 45.2 24.5 18.1 14.4 9.1 15.0 18.7 20.7 8.9 14.2 16.6 17.8

    Jubilant Life JUBLIF 470 710 Buy 7489 41.3 52.1 54.1 64.9 11.4 9.0 8.7 7.2 14.9 14.4 15.9 17.1 15.7 16.9 15.8 16.5

    Lupin LUPIN 694 755 Hold 31390 20.8 16.5 25.4 37.7 33.4 41.9 27.3 18.4 10.4 9.4 10.3 13.2 6.9 5.4 7.8 10.6

    Narayana HrudalayaNARHRU 235 260 Buy 4809 2.5 2.3 6.2 9.0 94.0 103.8 37.7 26.0 6.3 7.6 11.9 14.7 4.9 4.3 10.5 13.3

    Natco Pharma NATPHA 552 595 Hold 10026 37.7 34.9 35.9 26.4 14.6 15.8 15.4 20.9 27.4 21.3 19.3 13.1 22.7 18.5 16.1 10.7

    Sun Pharma SUNPHA 389 470 Hold 93236 13.0 15.9 21.0 23.9 30.0 24.5 18.5 16.2 9.7 10.3 12.4 12.6 8.2 9.2 11.0 11.2

    Syngene Int. SYNINT 309 358 Hold 12372 7.6 8.3 9.9 10.3 40.6 37.4 31.3 30.0 15.1 14.8 14.5 13.8 17.7 16.8 16.8 15.0

    Torrent Pharma TORPHA 1681 1,750 Buy 28440 40.1 48.9 51.3 72.9 41.9 34.3 32.8 23.1 11.2 14.2 15.4 19.2 14.7 17.5 16.1 19.6

    RoE (%)EPS (|) PE(x) RoCE (%)

    Source: ICICI Direct Research, Bloomberg

  • ICICI Securities | Retail Research 15

    ICICI Direct Research

    Monthly Sector Update | Health Check

    RATING RATIONALE

    ICICI Direct endeavours to provide objective opinions and recommendations. ICICI Direct assigns ratings to its

    stocks according to their notional target price vs. current market price and then categorises them as Buy, Hold,

    Reduce and Sell. The performance horizon is two years unless specified and the notional target price is defined as

    the analysts' valuation for a stock

    Buy: >15%;

    Hold: -5% to 15%;

    Reduce: -5% to -15%;

    Sell:

  • ICICI Securities | Retail Research 16

    ICICI Direct Research

    Monthly Sector Update | Health Check

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