Laurus labs is being added to FTSE All world index along with some other Indian companies - Linde india, Max Financial services etc.
Disclosure: Invested from lower levels.
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Laurus labs is added to nifty pharma index along with few other cos like gland pharma and granules.
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From the Laurus bio founder in LinkedIn. Interesting to note that they are walking the talk and executing on time (before time)
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Laurus lab is getting added to Nifty Pharma index of 20 scrips, with effect from/ available for trading on 30-09-2021. Along with present 10 scrips, newly added are- Abbot/ Alembic/ Glands/ Glenmark/ Granules/ IPCA/ Laurus lab/ NATCO/ Pfizer/ Strides, as per Index quarterly revision notice on NSE index.
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Good development - Although press release calls out target patients at 100000, per Unicef this is much larger at 25X+, or 1L target size is only for second and third line treatments - which is being developed by Laurus, Dev and commercial expenses being funded by unitaid, gains should mostly flow to bottomline.
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Arv space is getting crowded, Zydus Cadila receives final approval from USFDA for
Emtricitabine and Tenofovir Disoproxil Fumarate tablets. Lupin also received approval for the same.
Laurus is getting diversifying but arv is main cash cow, other big pharma companies are looking to tap into ARV. May be this is the reason for the weak price action being observed in laurus labs from the last one month. Every rise is being sold into. I request experts to make a comment.
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The question we need to ask is will any of new entrants dethrone Laurus from ARV dominance - it’s on back of cost leadership with volumes and scale - built over years - infact Laurus dominance is restricted by tender nature of ARV and 40% Cap( per mgmt own admissions). It is quite possible for new entrants to enter and participate in left over space, but if track records of any dominant player in API space is to be observed, once they are cost leaders with volume and scale, not easy to change that. Divi’s is a classic example of very large global share in many APIs and retaining/growing it. ArV Formulations are same story which builds on being backwards integration and API cost leadership. Unitaid and Clinton health press release in thread above is proof of Laurus capabilities and leadership.
The doubt if any will be the transition period performance from being ARV major to non ARV major, I.e. FY22 and FY 23, they knew that from long time that ARV is only going to grow in single digit and hence large scale Capex to enable that.( Many may prefer to be on sidelines and prefer to see how it plays out )
It is also likely and probable that QoQ/YoY excitement for all phenomenanl quarters of FY21 will not be repeated in FY22, Q1 22 had glimpse. This period may have its own narrative given moderate pace of growth( realative to FY21 quarters) and ARV reverting to single digit normalized pattern.
Looking through a 2+ year horizon and tracking Non ARV side growth development closely in line with mgmt walking the talk ( Non ARV API& Formulations, CDMO, Bio etc ) could help detach from short term stock price gyrations. $1B revenue journey is likely to see new business segments doing heavy lifting on growth - point is market need to see that happen.
Invested
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@Sakir_Saiyed
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If Europe had highlighted issues with Panexcell and Synchron in July 2020 wouldn’t Laurus have taken corrective action in the last 1 year 2 months?
Ideally Laurus should got this corrected by some other CRO in last 1 year 2 months.
Also if this was an issue why has Laurus not highlighted the same to investors post July 2020 on Europe and now in September 2021?
Is this wilful hiding of information or they have chosen not to disclose given there is no impact?
Also is this why stock has been correcting from Sep 17, 2021 or is this just coincidence?
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The US FDA notice is based on inspection done in 2019. How are you assuming Laurus has not taken corrective action in the interim period?
Inspection is done in 2019 but the letters are issued on 15 sept 2021. IMHO, no one was aware about this coming including Laurus so how they could have taken any mitigation action.
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Is only laurus labs engaged with these CRO or any other prominent pharma cos like divis labs ,lupin etc ? And the issue here is with the CRO’s not the pharma companies. And more over FDA has given a month time for the companies to submit data from other CROs.
I don’t have any knowledge in pharma related issues, but it doesn’t look like a big issue unless the pharma companies colluded with the CRO to falsify the data.
Checked with Laurus through a contact. There is just 1 product in US FDA list, which impacts Laurus a little. That too is so small that it is not even meaningful. US FDA had informed them about this in March 2021. They have already taken corrective action.
So does not make sense to blow this out of proportion!
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It is only Atazanavir which is mentioned in all the documents, this molecule is likely very tiny proportion of Laurus biz, finds mention among their dozen anti-virals as 2nd line therapy, never heard discussed by the management/analysts likely because of insignificance.
Anyway only automatic substitution is denied, and the base issue is already known since 3 years, and any fixing if done is possible within a year.
Would consider this practically zero impact. Share prices have been correcting as usual in consolidation phase between results, amid broader mid-cap weakness.
Disc: invested
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Seems to be too much ado about nothing 
and case of jumping to conclusions.
Pls refer the USFDA Q&A about Data integrity violations at Panexcell at the link:
As per the link, FDA has already changed the TE to “BX” for affected drugs, excerpt from above link below:
Will any of the affected products be taken off the market or recalled?
ANSWER: FDA has asked that within 30 days, companies respond with their plans to either repeat their bioequivalence studies at a site other than Panexcell or Synchron, or voluntarily withdraw their products from the market. FDA has changed the therapeutic equivalence (TE) rating for the affected generic products in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the “Orange Book”) to “BX.”
Quoting again from the Q&A, FDA has asked patients to check on the orange book whether the drug they are taking is affected or not:
How do I know if these data integrity violations affect a drug that I am taking?
ANSWER : FDA has restrictions on what it can legally disclose, because it is confidential information whether a particular drug applicant uses a particular contract research organization for studies it submits. Currently FDA has not identified any approved, marketed brand name products affected by the data integrity issue. However, if you are concerned about whether a generic drug you are taking has a “BX” rating, you can go to the Orange Book website and look up that drug. Type in the name of your drug and, in the list that comes up, look for the name of the manufacturer that appears on the bottle. Then look, for the drug and manufacturer, in the column TE Code. If the code is “BX,” you may wish to consult with your health care provider about continued use of the drug. (Many drugs have a “BX” rating for reasons unrelated to this action, but the drugs affected by this action have, as noted, had their ratings changed to “BX.”)
Going to the Orange book site at link Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations and search based on the “Search by Applicant (Company)” and by giving name Laurus Labs, gets the below list and none of the drug is classified with TE code “BX” for Laurus Labs. My interpretation is that this is not impacting any of Laurus Labs drug otherwise they FDA would have changed the TE code to BX already as stated by FDA in Q&A.
Most of the folks have become “bhav ke khiladi” and looking to find reason for any strength or weakness in stock price
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Do you have any proper data to back your claim of 10%sales drop or you making up this figure??
As per the above news article EMA banned panexcell validated products in july 2020 itself. Whereas laurus labs has informed in q1 concall that they have completed validation of product for contract manufacturing for its European partner in this year. Had they not been engaged with other CRO how can they get validation from EMA this year?
Request you to provide valid data to back up your sales drop figure.
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Just to confirm that this is indeed the right interpretation:
Searching the Orange Book for Lupin does show 9 drugs classified as BX, while all of Laurus’ approvals remain as AB.
Jefferies’ claim that the list is incomplete could be true, as Lupin is now up to 9 rating changes, Amneal is up to 31. (Although it’s possible that some may already have had BX status and aren’t new changes, but I don’t track these companies)
If the information from this source is true, we should expect one rating change in a few days.
Disclosure: invested.
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