- Ajanta has received final approval for Voriconazole Tablets (50mg & 200mg) from USFDA.
- Bioequivalent and therapeutically equivalent to VFEND® Tablets.
- Used in the treatment of fungal infections.
- Has an estimated market size of US$ 103 million for the twelve months ending Nov 2015 per IMS.
- To date - Final approvals = 10, Tentative approvals = 2 and Under review = 14 ANDAs.
Thanks Sandeep for the data provided.
I had one question though.
The company had 2 ANDA approvals prior to FY-2016 & has received 8 more ANDA approvals in FY-2106., yet there are hardly any sales in the US.
Can anyone help me understand the reason behind this ?
Also, what is the future outlook of sales to the US., for which the approvals have been received ?
I think the reason is they did not have US FDA approved facility…their US growth story will start from next year once their Dahej plant goes for commercial production…
Disc : Invested for long from lower levels
Did anyone attend agm? If someone could please add any updates you got from AGM.
Stock seems to have started steep upward trajectory after agm.
Disc: ajanta is 10% of my pf so have vested interest.
Some key points from the AR scanning -
- 8 products approved ; 5 commercialized ; 3 awaiting launch ; 2 ANDA approved; 16 under USFDA review
- Plan to file 8 -12 ANDA every year
- 4 facilities including Dahej that’s awaiting FDA approval and investing in formulation facility in Guwahati
- Within India presence in fast growing speciality chronic therapies such as opthalmology (rank 5), dermatology (13), cardiology (20) and pain management (45) ; In each category Ajanta grew faster than -IPM average in FY16
- Overall rank in India is 33 with 3000 MRs
- 5 yr stats - Sales CAGR - 26% ; EBITDA - 42% ; NI - 51% ;
- Both ROCE and RONW have seen decline in FY16 from 50% to 42% and 43% to 40% respectively
- In FY16 - Africa revenue grew 32% , Asia 8% and others declined 20%
- Given that Africa is today’s growth engine and Ajanta is clearly looking at US to be next growth engine - does it create a transition risk e.g. taking eyeballs off the forex movements?
They said the same thing last year and ended up filing low single digit. With no high value molecules in pipeline I doubt if US business will contribute meaningfully in next few years.
Disc: I exited few months ago and views could be biased.
Ajanta Pharma may be among the first to launch generic of US$ 400mn market size drug…
Ajanta Pharma receives approval for gZegerib and has launched the product in 2 strengths 20mg/1100mg and 40mg/1100mg capsules.
The Zegerid brand and generic had U.S. sales of approximately $ 306.7mn MAT for the most recent 12 months ending in May 2016 according to IMS Health (per DRL press release).
Shipment activities snapshot (source: zauba.com) -
Great work., Sandeep.
Ajanta Q1FY17 results are out. Revenue up 20%, PAT up 39%. Disproportionate growth continues.
Q1F17 Investor Presentation
Profit before tax has grown by 33%, but Tax has not increased anywhere proportionately. Tax has increased by 14%.
Lower Taxation (in Q4 FY16) was mainly due to higher tax benefits on incremental R&D capex - per ICICIDirect Q4FY16 Research Notes. Seems Q1 FY17 tax outgo is low due to the same reason. Tax experts please chim in…
Seniors who are tracking Ajanta, I have a question.
The quarterly result was already factored in at a price around 1500.
Without any new triggers why is there sudden spurt in price to 1900 ?
I am unable to connect the dots.
Please advice, is this just because of Dahej.
The PE was already too high even at 1500, and the price has now further increased to 1900.
- Ajanta gets tentative US FDA nod for Eletriptan Hydrobromide oral tablets (20mg and 40mg)
- Generic of Relpax by Pfizer
- Two patents (expiring in Dec '16 and Aug '17)
- One Para IV challenge (submission date 3/29/2010). Most likely by Apotex.
- Four tentative approvals currently (Apotex, Ajanta, Mylan and Teva)
- Used to treat migraine headaches
- Ajanta received USFDA approval for Olanzapine, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg.
- It is a generic version of Eli Lilly’s Zyprexa.
- Used for the treatment of schizophrenia, bipolar disorder
(about 1% of Americans are said to be suffering from this illness).
- FDA oked the first generic in Oct 2011.
- Total 14 approvals currently (Ajanta, Alkem, Apotex, Auro, DRL, Mylan, Sun, Teva, Torrent and others).
- Had ranked among the top eight drugs in sales each year from 2000 to 2007.
Eli Lilly’s Zyprexa U.S. sales were $157 million in 2015. Helps to gauge U.S. market size.
Market for Aripripazole is getting crowded. Ajanta also getting approval http://corporates.bseindia.com/xml-data/corpfiling/AttachLive/99A38AFD_FD31_4A35_BCF2_AC4B0D119DF0_112230.pdf.
Can you please share your views on this :
- What has been the price erosion of Abilify until now, since going off-patent ?
- Given the present rates., can you put an estimate to the margins on aripripazole for a generic producer ?
In short,i am trying to gauge what would be the impact size of this approval on Ajanta’s bottomline.
I found the rates to be as low as USD 0.15 for a 5 mg tablet.