Plank 1: API Opportunities are again mainstream today . Industry opportunities are consolidating. API manufacturers with process/cost efficiencies and scale are taking away larger market share in their key products.
Product Selection philosophy: There are huge opportunities today. But we need to be cautious. Led completely by whether the Management believes they can get to a global leadership position. Global Leadership position implies >25% global market share (eventually)
2020 API situation
Currently, 7 Products enjoying more than 25% global market share
Another 3 Products enjoying more than 15% global market share
Working on more than 6 more APIs where Laurus can get to leadership position
Confident of at least 15 products > at least 25% global market share in 3-4 years Source: Management Interview July 31 ET Watch 6:27 Min onward
New Opportunities from API Supply Chain disruptions for Laurus - Medium Term Driver
Concrete interest in Non-ARV APIs and Contract Manufacturing APIs. API Source change takes anywhere between 18-24 months. New business opportunities 2 years down the line. Lot of Opportunities as per Mgmt
There is lot of work we can do take forward these data-points and firmly establish the addressable dominant market share opportunity for Laurus. In ARV, Oncology, Hep C, and other APIs
Emtricitabine (~25% market share)
slightly dated source: here
The fact that in ARV Market there is limited competition because products need to be approved by various regulatory agencies, and WHO pre-qualification is required (unlike say Hep C market where anyone can still launch in India by buying API from non-approved sources as well); Global funding that encourages Scale if the required quality is met are big advantages working in favour of Market Leaders.
How does Laurus maintain and increase global market share (in the face of stiff global competition)? [source: slightly dated [corporate brochure] presented at IAS Conference, Amsterdam, July 23-27, 2018
Disclosure: Invested from lower levels. Thanks to the conviction/hard work of @rupeshtatiya and the structural tailwinds for API, it started out as an easy Opportunistic bet in early June. That there was more to the story, became increasingly apparent on richer conversations with believers & skeptics alike. Felt compelled to energise everyone for a more structured deep-dive. Please excuse inevitable mistakes; and allow me couple of days to lay out what excites me about the business. Familiarity with the business is just 2+ months, so look forward to learn from those more familiar, and tracking/invested.
NOT a recommendation. Current levels may not leave much margin of safety. It’s important for us to understand/dissect the fundamentals of the business properly, first.
Plank2: Finished Dosage Formulations (FDF) has finally become mainstream. Finally delivered on product development and building a large scale manufacturing base built up over last few years. Company’s strategy of diversifying the business mix has started to pay off. FDF’s now comprise 36% of Total Sales.
Primarily 3 segments
ARV Formulations in LMIC Markets (75% Contribution)
Product Selection Philosophy
Forward Integration only. ONLY in such Formulations where Laurus has the API process efficiency/scale (?)
Plank2A: ARV Formulations [Low Medium Income (LMIC) markets] A Tale of Two Pills – How the TLD/TLE transition is taking shape within PEPFAR (ARV Formulations)
US Formulations - Pregablin maintaining high- teens(?) Market share, Metformin high single digits (?) market share; at least 4 new Products to be launched in FY21
I have done some work on the DMF filings of Laurus Labs - trying to guesstimate the API market size based on formulation size (patented/non patented) etc. The same is summarized below and the detailed sheet is attached. There was no perfect data and this exercise is more of a guesstimate. Pls let me know if you find any aberrations. Few interesting ones are highlighted in yellow.
(API sizes in $ mn)
This Collab work for Laurus is turning out to be very interesting, as most of you would have noticed! Must make special mention of @spatel and @YachnaBhatia for exemplary collaboration work ethos. Also @iivans has shown good early promise and initiative. @Gaurav_Agarwal is finding his feet, but persisting. Both Ivan and Gaurav simply put up their hands and requested to join the collaboration effort, so can anyone - newbie or senior - there are assignments to be handed out at every level.
Now that over, let’s try and articulate how should we think about all that data that has emerged, in the backdrop of what we already know about the Business and Management intent. They have been quite vocal about the direction they are taking/likely opportunities in the market. Also how/why further Scuttlebutt will help
We will be progressively sharing more inputs as they emerge from scuttlebutt dialogs with domain experts based on this solid-solid base. In my mind this collaboration effort has surpassed all previous such efforts (I have been part of), and sets a new benchmark for others to follow. I have no doubts, that we are very well equipped now, to extract more nuanced connect-the-dots type of Insights into Laurus business, as we persist with taking this forward. We are close.
Some initial observations:
As someone has mentioned before, Formulations focus is the way forward and THE main growth driver. Formulations where Laurus has the inherent API capabilities/strengths. So the clues ARE in the API list (and the raison d’etre), but hey you the discerning reader might note - the Moolah is probably coming from addressing the Formulations Market…he he . Interesting ways to handle the trade-offs of (R&D/ANDA Filing/Front-End) Cost vs Opportunity. We have already seen Laurus taking self-confident bets and getting out of many Partnership products. I would think another way the ANDA gaps could be filled up is by buying out Dossiers even (where they are very sure of inherent API strengths, and the Market is LARGE enough). This helps bring everyone on the same page I hope on how important it was to nail down specifics in the above list. (Kudos to the Team again!).
The list above from Consent Orders of State Pollution Control Board for all Units shows us the indicative direction Laurus may be taking. For many of the approved API/Intermediate products you might have noticed already, there are no DMF Filings - it only means these are probably under development, and will be filed progressively in sync with emerging opportunities. At the same time, please NOTE that Group capacities are FUNGIBLE today (from a regulatory/PCB permissions perspective), some of the product expansions could be a smoke-screen (?) for the more promising ones that will stay hidden till D’day. [On the flip side, you cant help notice the transparency w.r.t. to products in decline, so hey you better take every product expansion seriously and investigate as much as possible with domain expert help!]
One other aspect that may strike some discerning folks like you. There are many products figuring in the list above – where apparently there isn’t a good enough/attractive market. We perhaps should also take into account that a few/many of these opportunities may also be led by Contract Manufacturing opportunities (esp. KRKA) where the Partner may have inherent strengths.
While trying to piece-together some more areas that may just not make commercial sense anymore to a new entrant (like for say an old product like Capecitabine, where others have a stranglehold) there may be possibilities of selling such products to players looking to complete the product basket for a more attractive offer to the trade/distributors.
During the Scuttlebutt with domain experts we should always try to get a FEEL for the Mkt share enjoyed cumulatively by the Top 5-6 players. If that is say 80%- then there is probably very little scope for a late entrant (like Laurus) to muscle in, and take a sizeable share. However if that share is 50-60%, then the picture looks different! Interesting possibilities could be there
If you have friends in the industry, you will do well to connect/attract folks who have access to IMS/IQVIA Reports – this whole job becomes a much easier nut to crack.
When all the dust that we are kicking up finally settles down, we may come down to what we already know – that DTG Doletugravir on the API side, and DLT/TLD on the Formulation side are THE products to drive growth during near future
But hey, this focus at VP is NEVER about the near term, is it? It is to get more clearer about the medium term – develop that all important FEEL – of where this business is headed in the next 2-3-4 years.
There will always be insufficient information – based on which we still have to determine the ODDS (true for every competing equity investment you/me may be pursuing). We have always found this pursuit rewarding, because it helps us separate the wheat from the chaff.
At the least, we would help everyone become better-informed investors in the business, and therefore be in a position to extract more - out of every subsequent Management Interaction.
I am on the job consistently on parlays with domain experts to understand this puzzle better & better. Inviting each one of you to help us attract more domain expert friends. How do we do that? I believe there is enough MEAT in this thread put up by the Team. Just pointing them here, for a crisp look up should be enough. Thanks in advance for your help!
I have been receiving many queries on Laurus Product Roadmap/Sustainability (mainly ARV). Technology Obsolescence is cited as a Key Risk by some. Competition with its Customers (other Formulation players) is also seen as another significant risk. Business Model Vulnerability is cited as another. If you ask me - I find all these doubts/objections are first-level-thinking - without bothering to put all facts on the table!
I have been referring them back to a key Laurus document (2018 vintage) uploaded by me right at the starting post, if I am not mistaken. LaurusCorporateBrochure-Final_.pdf (1.3 MB)
This answers much of these doubts - and gives one a proper headstart for those interested, to begin digging deeper. Surprised that none of these guys/gals have bothered to read this one presentation in detail, and take forward. The same document gives us important clues how to think about/ask domain experts specific/relevant questions on Laurus Future potential.
Thought it important enough to flag again - to bring everyone on the same page quickly, so we can all do a better scuttlebutt job. There is just one person (I know) who has taken this document seriously, and therefore has progressed a bit in taking the Scuttlebutt work further. Have requested him to update his work in this thread/reveal the inner workings of how his mind looks to take this forward,
Let’s take on Technology Obsolescence (ARV)/Laurus ARV Runway risks first. Much easier to dismiss.
The counterpoint to technology obsolescence risks/worries in my mind it is pretty simple
Laurus has a pretty simple job to do - follow the lead of the Innovators - blockbuster launches from Gilead, GSK, Viiv (JV of GSK & Pfizer), Abbvie (Abbot Research) keep working on this easily identified API Pipeline, and file DMFs when ready. Now that it has started demonstrating Formulations success too, file ANDAs or buy Dossiers (?)
As an example, lets check out the blockbuster ARV drugs of last few years, especially 2019-20; not that difficult to establish even without IMS data Biktarvy ARV Market.pdf (194.3 KB)
BIktarvy (Gilead) triple combination drug - daily, fixed-dose combination of the integrase inhibitor bictegravir (BIC) plus two nucleoside reverse transcriptase, inhibitors (NRTIs), emtricitabine (FTC) and tenofovir alafenamide, fumarate (TAF)
Question to ask:
a) Does Bictegravir feature in Laurus Plans - YES - Source Laurus Corporate Brochure Amsterdam Presentation 2018. FTC and TAF are existing Laurus products
b) Are they anywhere close to Bictegravir DMF - UNLIKELY - Source Laurus Capacity Expansion Docs. Only Hetero seems to have filed Bictegravir DMF (?) -Source USFDA excel 2Q2020
c) Are they on the right track - for sure
As per one IQVIA/IMS source, last 3 years Biktarvy Total Sales in US $1.33 Bn (2018), $5.12 Bn (2019), $3.9 Bn (2020).
Further questions to ask:
a) LMIC continues to account for 80% of ARV Formulation Sales? Proportion of US/EU sales going up perhaps unlikely in next 2 years. But can likely become 30-40% in 3-5 years? What all will Laurus have to do for that?
b) Meanwhile can ARV API sales proportion is US/EU register big jumps? why or why not?
c) do the earlier API technology Licenses from Gilead, Merck and others preclude Laurus from non LMIC Sales? Have they developed alternate processes for same APIs by now? To check
d) How to focus better on LMIC Formulation prospects - inclusion in WHO List is the main driver?
Urging everyone to spend more time on individual ARV products in developed markets/Scuttlebutt for same. Now that Laurus has a more complete ARV product basket, it is far easier to establish where the ODDS lie - if we are willing to devote some energies on this. Bictarvy was just one example. Many more there??
But when focusing on near-to-medium term - LMIC Formulations focus, and establishing the main visibility/drivers will be more important.
Long term possibilities. Encouraging to see Laurus has all the required APIs (except two red text marked ones). That said, innovators keep disrupting the market with fresh combinations. Ex.
Atripila sales were $3.4bn in 2014 and $0.6bn in 2019
Stribild sales were $1.8bn in 2015 and $0.4bn in 2019
Complera sales were $1.4bn in 2015 and $0.4bn in 2019
Biktarvy sales were nil in 2015, $1.1bn in 2018 and $4.7bn in 2019
**ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1
We know that Laurus Labs has signed licensing deals with ViiV Healthcare (from Annual report FY 20)
Laurus had also mentioned in Q1 transcript that the increase in ARV API sales is largely from Tenofovir, and third party sales of Lamivudone ad Dolutegravir.
Request @spatel, @YachnaBhatia and others interested/invested in Laurus Labs to try and take this forward, dig in and point what’s still missing, what more do we need to get an even better handle
@PharmaProfessionals at VP
Guys/Gals - if you can help with taking this work further, have access to IMS data (direct or indirect) and the domain knowledge to add value to this exercise, please send private mails to @spatel@YachnaBhatia@donald to be counted in!
Disclosure: Invested from lower levels. NO transactions in last 30 days
Laurus Bio - Q2 some revenues will come and full benefit will come H2
150cr capital outlay for dedicated R&D for Laurus Synthesis
2 products for EU partner are in Diabetic portfolio and Laurus is fully integrated in these products. From the work done by @spatel bhai on this thread, following are some of the APIs in diabetic segment.
Truvada - already launched - close to 10% market share in US
From Teva’s conf call, Teva has 180 day exclusivity for this product and they launched in Q4 CY20. The exclusivity expired sometime around March 2021. I think the price erosion in this segment would be more than 80-90%.
4 products validated in FDF - only 1 can be commercialized, need ANDA approval for rest
These product validations are like pre-ANDA filing validations is what I understood. So these are like outcome of R&D spend and will get commercialised over 3-4-5-6 years.
Margins gain from brownfield will be nullified by pre-op expenses for greenfield
Reiterating 1bn$ target for FY23 - on track
8-10% of ARV API sales come from regulated markets
KRKA relationship - exclusive partnership - only KRKA or Laurus makes
Validating two 2 APIs in Oncology in FY22
CDMO might contribute 20% of revenue over next 2 years, Bio - 5% revenue
Next Global Fund cycle is in next quarter. With new players like Lupin getting approval, would be important to track allocations that Laurus gets.
Disc - Invested from much lower levels, views are biased, not a buy or sell recommendation. I am not SEBI registered IA. Please do your due diligence before investing.
Global Life Sciences company CDMO - qualification to happen in H2FY24. Multi year, multi product contract.
4 intermediates, 3 APIs - commercialized. Good number of late stage products.
FDF
EU formulation - some revenue in Q2, majority revenue in Q3 onwards
Civil infra can support 10bn additional capacity, only 5bn is installed now. FY24 - we can thinking of adding another 5bn.
ARV
Except for South Africa, some of the country tenders went to winner takes it all. Roughly 10% tenders have become winner takes all category.
It looks like all the pricing, tender related risks are playing out in ARV segment.
EU Non-ARV product launches and Multi Product, Multi Year CDMO contract with dedicated facility are two interesting things happening.
Whether the CDMO revenue bump up is a one off or not would only be known in hindsight.
. Interesting ways to handle the trade-offs of (R&D/ANDA Filing/Front-End) Cost vs Opportunity. We have already seen Laurus taking self-confident bets and getting out of many Partnership products. I would think another way the ANDA gaps could be filled up is by buying out Dossiers even (where they are very sure of inherent API strengths, and the Market is LARGE enough). This helps bring everyone on the same page I hope on how important it was to nail down specifics in the above list. (Kudos to the Team again!).
