Alembic Pharma (Oral Solids ==> Injectables, Onco, Derma, Opthalmic)

https://www.screener.in/insiders/details/48061/

Acquisition of 18,064 equity shares worth Rs 173.97 lacs by promoter & director

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Alembic pharma has been under ‘watchlist for unsolicited messages’ for sometime…
Can anyone throw light on the exit criteria from this list?
Regards,
Abhijit

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I wondered regards this too. Turns out it’s just a warning to potential investors tha a non sebi advisor is sending SMS/tips in some other fashion without the permission of the receiver. Someone must have complained regards the spamming and the warning has been put up. Not a list with any ramifications for alembic I think… just the spammer who sent the tips

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Alembic Pharma Receives USFDA approval for breast cancer Drug- Palbociclib Capsules, 75 mg, 100 mg, and 125 mg

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It seems Alembic Pharma is no longer in this watchlist :slight_smile:
Regarding the press release which accompanies every ANDA approval, the estimated market size (for instance 600 million $ for Palbociclib) is always outlined.
On what basis should one estimate the probable market share for Alembic Pharma ? ( I know for this one, there is litigation ongoing with PFizer).

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https://www.crisil.com/mnt/winshare/Ratings/RatingList/RatingDocs/Alembic_Pharmaceuticals_Limited_November_18_2020_RR.html

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TG Therapeutics laid out post-approval launch plans which indicate that Umbralisib’s combo U2 is on track for an early 2021 filing ( Positive for Alembic as per a note published today by Jeffries) .

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Alembic Pharma Q2 concall highlights -

  1. Sales at 1457 cr - up 17 pc, EBITDA at 455 cr - up 33 pc, EBITDA margins at 31 pc, PAT up 35 pc at 333 cr. Half Year revenues up 28 pc at 2800 cr, EBITDA up 61 pc at 871 cr, PAT up 72 pc at 635 cr.
  2. Capex for the Qtr - 168 cr. H1 capex at 311 cr. Total capex with pre operatives at 1825 cr ( includes all CWIP ). Fin assistance to Aleor JV for HY at 65 cr. Total investments in aleor at 742 cr. Money raised via QIP during the qtr at 750 cr…used for partial payment of debt and for funding future growth. Gross borrowing stands at 600 cr vs 1440 cr in Jun 2020. Cash in hand at 273 cr. Net debt / equity at 0.07- thats comforting !!!
  3. Q2 India sales at 415 cr, up 6 pc. Good uptick seen in Sep. Very good growth in Oral Azithromycin. Good improvements seen in Gastro and Gynecology, they were previously lagging. Company expects strong growth in Q3 in India business. Company putting in a lot of efforts to accelerate Uro, Antibiotic and Cardio portfolios. Cough and Cold , Pediatric segments showing negetive growth - in line with mkt.
  4. Intl business - Good growth in API and Generics business. R&D at 13 pc of sales at 185 cr ( this is always high at Alembic vs peers ). Launched 3 products in US in Q2. Expect to launch 5-6 more in Q3 !!! The drug discovery venture - Rhizen has outlicensed its oncology molecule Umbralisib to TG Therapeutics. TG is targetting Umbralisib’s regulatory clearence for CLL ( chronic lymphocytic leukemia ). Rhizen also entered licensing arrangement to develop and commercialize its second oncology product Tenalisib with Curon Bio Pharma.

Intl formulations sales at 779 cr, up 21 pc. US generics at 582 cr, up 8 pc. Last years base was high. Ex- US sales at 197 cr, up 84 pc.

API sales at 263 cr, up 30 pc.

  1. Company has guided for an EPS of Rs 60 for this yr and Rs 50 for next year despite additional expenses of 450 cr hitting the P&L on account of new formulations plants ( due agressive capex ). Company expects increase in revenues in FY 23 but not giving any guidance for the same.

Above guidance provided to allay fears and to assert that the current business is sustainable.

  1. The 450 cr additional expenses brought out for FY 22 will be of reccuring nature every year ( this includes depreciation on new plants and there wont be any capitalization ) . These are likely additional operating expenses for new plants.
  2. Total launches in first half - 6. Launches lined up for second half- 10 to 15. So, company may end up with 15-20 launches for the full yr. Next year - similar numb of launches or slightly more. Injectables launches - next year. Pricing pressures in US - manageable.
  3. API capex now being easier to execute due faster environmental clearences vs past due govt focus. Some API capacity expansion already underway.
  4. Company aims to hit a $ 400- 500 million kind of revenues in US - 3 yrs from now. Growth drivers - Injectables, Onco - Injectables, Derma and Opthal products. Presently, company is clocking roughly $ 300 million annual US sales.
  5. Management admits that hitting the first $ 500 million revenues in US is not as hard as growing from thereon. They dont want to get into biologics and bio similars due heavy upfront investments. They will evaluate future growth opportunities only after stabalising the current capex…so that may be 2 yrs from now.

Disc : invested.

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Last figure I am aware of regarding Alembic Pharma’s Management Compensation as a % of Sales was 1.40%. As far as I am aware, this is the highest in pharma sector, have there been any changes to this ?

Hi All,

Sharing my notes from company’s latest credit rating report.

Regards,
Yogansh Jeswani
Disclosure: Invested

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image

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Another USFDA approval today:
Alembic Pharmaceuticals announces USFDA Final Approval for Metolazone
Tablets USP 2.5 mg, 5 mg, and 10 mg.
Alembic Pharmaceuticals Limited (Alembic) today announced it · has received
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New
Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. The
approved ANDA is therapeutically equivalent to the reference listed drug product
(RLD), Zaroxolyn Tablets 2.5 mg, 5 mg, and 10 mg, of Lan nett Company, Inc.
Metolazone Tablets are indicated for the treatment of salt and water retention
including: a) edema accompanying congestive heart failure; b) edema accompanying
renal diseases, including the nephrotic syndrome and states of diminished renal
function. Metolazone Tablets are also indicated for the treatment of hypertension,
alone or in combination with other antihypertensive drugs of a different class.
Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of
US$ 33 million for twelve months ending September 2020 according to IQVIA.
Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19
tentative approvals) from USFDA.

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Hi @topdog,
Stock recommendations are not given in valuPickr.
There is enough information on the history of the company,it’s future plans and opinions by many stalwarts of this forum
You are requested to go through these posts and conclude yourself.
Regards,
Abhijit.

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The first part of the comment is for Dr Reddy’s.
In the second part of his tweet, he talks about inspection of Alembic’s new sterile unit.

As per FDA site, their Tajpura site got inspected in March 2020.
https://www.accessdata.fda.gov/scripts/inspsearch/index.cfm

Any idea which one of these sites is the one for sterile?
https://www.alembicpharmaceuticals.com/manufacturing/

I am assuming it is their Panelav and Karkhadi plants.

I tried looking up but couldn’t find anything other than this comment from their May 2017 concall.

Also, my understanding is facilities don’t get inspected by the FDA for years, at a stretch, due to FDA’s internal reasons (logistical & political).

Wondering what implications an audit on one of their sterile facilities have, whenever it does happen?

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Basically Sterile plant has stringent inspection criteria and passing inspection confirm that you have arrived on compliance front.

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As per shareholding pattern for Dec’20 Qtr, LIC of India has entered Alembic Pharma with 1.01% stake:

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CFO Interview on Dec 15, 2020:

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Q3 Results

• Net Sales for the quarter up 9% to Rs 1314 crores from Rs. 1209 crores.
• Net Profit for the quarter up 25% to Rs 293 crores from Rs 234 crores.
• Net sales for 9M FY21 up 21 % to Rs 4113 crores against Rs 3399 crores.
• Net profit for 9M FY21 up 53% to Rs 927 crores from Rs 604 crores.

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