I did not see this disclosure FDA Confirms Recalls of High Blood Pressure, Heart Drugs Over Carcinogens | The Epoch Times
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Further to my last post on inlicensing above today Glenmark has announced inlicensing of hengrui’s shr-a1811
It is currently in phase ii/iii and has high efficacy and safety data.
Application in breast cancer , lung cancer, gastri, esophageal , colorectal etc
breast cancer market alone for her2 therapies is approx 13 bn usd.
One more inlicensing deal done for oncology. The drug is a sucess in china with sales of 40 bn RMB approx 1200cr pa. They are going to be big in oncology in ROW and India by the number of novel drugs inlicensed and developed inhouse (isb 2001) in their portfolio.
There is a possibility that isb 830 which they had outlicensed to astria may be bought back, as astria has a change in mgmt and new mgmt is focused on other pipeline drugs of astria. Glenmark is aware of the possibilities of isb 830 and by some statements might bid for the asset. Check grok or other AI tool for possible commercial value of isb 830.
Estimated increase in PAT due to pipeline drugs… timeline of milestone payment and amount is rough conservative estimate basis public information
Like isb 2001milestone payment for isb 2001 will be 1.2 bn usd in total, so for phase 1,2,3 it should be roughly 200 mn usd each and balance on marketing Authorization but I have taken only 50 mn each
Further detailing the injectables/ para iv/ biosimilars filing we have pipeline of gvoke, iron deficiency, etar ncept, trastazumab, bevacizumab etc mainly for usa and ROw.
Europe has been doing well but the pipeline looks weak as of now. India, Row & usa pipeline has something or the other.
Notes on Glenmark Pharma -
Q4 outcomes -
Revenues - 3771 vs 3256 cr
EBITDA - 763 vs 561 cr ( margins @ 20 vs 17 pc )
Other income - (-) 184 vs (-) 364 cr
PAT - 301 vs 4 cr
FY 26 outcomes -
Revenues - 16983 vs 13322 cr
EBITDA - 4572 vs 2351 cr ( margins @ 27 vs 18 pc )
Other income - (-) 1805 vs (-) 259 cr
PAT - 1362 vs 1047 cr
Glenmark - AbbVie deal -
Company entered into a licensing deal with AbbVie ( a global innovator ) in Q2 FY 26. They received an upfront payment of 6200 cr ( aprox ) in Jul 25 for joint development and out licensing of their NCE molecule ISB 2001. They recognise receipt of aprox 165 cr / Qtr from AbbVie / Qtr - in the P&L for accounting purposes
AbbVie shall develop and commercialise the molecule for North America, EU, Greater China, Japan mkts. IGI ( Glenmark’s innovation led subsidiary ) shall co-develop and commercialise the same for India, LatAm, EMs, CIS and Aus/Nzl mkts
Glenmark is entitled to receive another 9200 cr ( aprox ) - linked to achievement of various developmental and commercial milestones. They are also entitled to receive royalties on sales ( in double digit revenues )
IGI’s annual burn rate is aprox 650 cr. The upfront payment of aprox 6300 cr ensures that IGI remains self funded for foreseeable future
ISB 2001 is a first in class, tri-specific antibody targeting multiple myeloma
Breakup of Q4 revenues -
India - 1020 vs 943 cr, up 8.2 pc
North America - 924 vs 714 cr, up 29 pc ( led by out-licensing deal they struck with AbbVie )
EU - 890 vs 733 cr, up 21 pc
EMs - 879 vs 789 cr, up 13.7 pc
Breakup of FY 26 revenues -
India - 3723 vs 4484 cr, down 17 pc ( their India business de-grew by 87 pc in Q3 due implementation of new GST rates. Glenmark was after more than others as they follow the legacy 3 tier distribution system )
North America - 7139 vs 3017 cr, up 137 pc ( led by out-licensing deal with AbbVie )
EU - 3100 vs 2846 cr, up 9 pc
EMs - 2940 vs 2813 cr, up 4.5 pc
Other highlights for FY 26 -
Launched 13 new products in US. Received first generic approval for FloVent with a 180 day exclusivity. Received approval for Fluticasone OTC nasal spray in US
Commercialised 20 Injectable products in US through partnerships
Initiated commercialisation if Riyaltris in US
Monroe Facility in US received VAI classification after an FDA inspection
Riyaltris sales sustained momentum in the EU and various EMs. Have commercialised Riyaltris in 55 markets now. Launched it in China and Thailand in Q4. Initiated commercialisation in US in Q1. Riyaltris sales grew by > 50 pc in FY 26
Winlevi gained traction in UK since its launch in Q1. EU launch should happen in FY 27
Company’s speciality brands -
Riyaltris ( used to treat Allergic Rhinitis ) -
Shall continue to remain under patent till mid 2031. It’s a nasal spray combining - Olopatadine + Mometasone. Its patent is that of the formulation + particle size + suspension chemistry + delivery system of the a/m generics. The combo was developed completely in-house by Glenmark. Riyaltris clocked aprox 900 cr in sales in FY 26. Management believes, it can clock sales > 2000 cr / yr
Winlevi ( used to treat Acne Vulgaris ) -
They In-Licensed Winlevi from Cosmo Pharma NV in Sep 23 for 15 EU mkts + RSA + UK. FY 27 should be the first year of significant revenue contribution from Winlevi as it gets rolled out in EU countries. Company expects Winlevi to ramp up to > 500 cr in annual sales by FY 30
TEVIMBRA ( Onco drug - Biologic ) - In-licensed from BeiGene ( a Chinese MNC ). Launched in Q1 LY in India
BRUKINSA ( Onco drug ) - In-licensed from BeiGene ( a Chinese MNC ). Launched in Q1 LY in India
JABRYUS ( used to treat Atopic Dermatitis ) - In - licensed from Pfizer for sale in India. Launched in Q4 FY 24
LIRAFIT ( Lirglutide’s Biosimilar ) - launched in India. Glenmark is the mkt leader
GLIPIQ ( Semaglutide ) - launched in India in Mar 26
QiNHAYO ( Onco drug ) - In-licensed from Jiangsu ( Chinese MNC ) - for India and RoW mkts. Have submitted MAs ( marketing authorisation applications in 24 countries )
UpComing launches in FY 27 / 28 -
Aumolertinib ( Onco Drug ) - launch expected in FY 27. In-licensed from Hansoh Pharma ( China ) for launch in India and EMs
Trastuzumab Rezetecan ( Onco Drug ) - Launch expected in late FY 28. In Licensed from Hengrui Pharma ( China ) for EMs and India
All these speciality drugs put together should have a peak annual sales potential of upto 7000 cr / yr in next 5-6 yrs
Glenmark’s India business highlights -
Therapy wise rank in India -
Cardio - 4th
Derma - 2nd
Respiratory - 3rd
Company is Ranked 13th in India
Their top 5 bands in India -
Telma franchise, Cardio > 900 cr
Ascoril franchise, Respiratory > 400 cr
Candid franchise, Derma > 300 cr
Alex franchise, Respiratory > 200 cr
Momate franchise, Derma > 150 cr
10 of their brands clock sales > 100 cr in India
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Glenmark Pharma -
Q4 FY 26 concall highlights -
Riyaltris launch in US and Winlevi in EU should be key growth drivers in FY 27
Have got 180 days exclusivity for gFLOVENT ( anti-asthmatic inhaler ). Shall be launching in FY 27. Have also got 180 exclusivity for gFLONASE. Also slated for a FY 27 launch
Launched Tevimbra and Brukinsa in India in Q1 - seeing good response from the mkt
Launched Nebsmart in India in Q3 LY - world’s first triple molecule combo for treatment of COPD. Like Riyaltris, this is an in-house innovation
Their OTC brands like - Candid ( anti fungal dusting powder ), Scalpe ( medicated shampoo ) LaShield ( sunscreen ), Episoft ( moisturiser ), Elovera ( moisturiser ), Bontress ( anti hair fall ), D’Acne ( skincare ), LiteGo ( skin brightening ) - clocked double digit secondary sales growth in Q4
Ex of the payments received from AbbVie, their US business grew by 8 pc in Q4
EU growth in Q4 was led better off take of their branded products
Plan to launch 2-3 more respiratory products each in EU and US mkts in FY 27
Plan to also launch Riyaltris in Brazil in FY 27
Launched Riyaltris in China + Thailand in Q4 FY 26
IGI’s under development assets like - ISB 2301 ( Onco therapy ), ISB 2501 ( small molecule, Onco therapy ) - also look promising. ISB 2301’s IND ( investigative new drug ) application is expected to be submitted in FY 27
Company expects FY 27 to be a strong year for them. Expecting revenues of 17-18k cr in FY 27 with EBITDA margins between 20-21 pc for FY 27. Will share more about the growth drivers in the upcoming investors day discussion
Company is now net debt free ( after receipt of upfront payments from AbbVie )
Company expects their growth rates in India + EMs to remain elevated for next 4-5 yrs as they are launching a slew of in-licensed drugs ( mostly in-licensed from Chinese innovators )
Expecting high teen growth in India + EMs + US. Expecting EU growth to be in high single digits for FY 27
Riyaltris clocked revenues of aprox 900 cr in FY 26. Expecting this brand to keep growing @ 30-40 pc CAGR for next 2-3 yrs. Its now a global brand being sold in 55 countries
Riyaltris clocked revenues of aprox 900 cr in FY 26. Expecting this brand to keep growing @ 30-40 pc CAGR for next 2-3 yrs. Its now a global brand being sold in 55 countries
R&D expenses should continue to remain @ 7-8 pc of sales for FY 27 as well ( like in FY 26 )
Disc: initiated a tracking position, may add/ reduce depending on results going forward, biased, not SEBI registered
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The above plus their q1 commentary makes the path look like the below:–
Flovent/ winlevi/ ryaltris will lead growth in q2/q3 and 4
Followed by respiratory launches in usa alongwith aumelortinib in ROW
Followed by meaningful injectable launches in H2 fy 28 + trastazumab+ envafolimab
Milestone payment from 2001 likely in 5-6 month