Alembic & Alembic Pharma

(bbbhutra) #412

Alembic Pharma on Friday has entered into the oncology segment by inaugurating anti-cancer manufacturing facility at Panelav, Halol, Gujarat.

The manufacturing facility is designed with containment control automated standards and major equipment imported from Europe. With this facility, Alembic Pharma will commence exporting oncology products to US, Middle East, North Africa, Australia and South Africa.

(Mukesh Tolani) #413

A rare precedent this in the Indian corporate scene.

Minority shareholders demand a seat in the board of directors of Alembic Ltd.

(ragav) #414

Q118 results have factored in the news of lower sales and DE - Growth in USA in its stock price .
A 12 % lower growth in revenues EBITDA Margins Post R&D at 16 % vs 21%

Of the 3 vertices of the company Indian formulations, International formulations and Api Business there seems to be only 2 % growth in API business. Other 2 verticals have dragged down growth .

The company has said it has filed for 4 DMF, and as per the USFDA ORANGE BOOK the 4 DMF for this Q118 are

  1. Macitentan - 93 mm $ in sales
  2. Riociguat - 50 mm $ in sales
  3. Afatinib dimaleate - 36 mm $ in sales
  4. Ivacaftor - 24 mm $ in sales

So I can see not all the drugs at having a big market sales when compared to other products like Aripiprazole gAbilify, and there could be meaningful competition too in these drugs. I would watch the launches and DMF being filed by the company in future Quarters and the company has said that it would be launched 100 Anda commencing 2018 so which would be a great revenue drive I believe.

Disc : Invested in ALEMBIC pharma , opinions are my own and can be biased.

(arunjacob) #415

alembic pharma sells its baddi formulation manufacturing facility .Not sure of the motives here . could this be a red signal ?

(Nityanand) #416

Dont know about the sale of Baddi unit here, but they are coming up with new facilities at Panelav. Construction of a new plant will start in few months.

I got to know this as my job profile allows me to visit the clients in Gujarat and I get to know about the developments.

Disc: No investment in Alembic

(Rohit Ojha) #417

As per press release the Baddi plant contribution was negligible.
If you go 2-3 years back annual reports, it said that this plant was formulations plant for India and emerging markets. It seems that the plant either had low capacity or was not operational. Anyhow, there must be a land value at least.

(bbbhutra) #418

Transcript of Q1 2018

Alembic Pharma.pdf (101.4 KB)

(Vikas Pandey) #419

alembic pharma bought Orit Laboratories LLCac2b6749-34d8-49eb-a355-c14be6433ad3.pdf (666.7 KB)

(bbbhutra) #420

(Rohit Ojha) #421

The recent ANDA approvals of Alembic have been petty change. Really very small market sizes. I wonder whether these will make any difference to their numbers. Another way to look at it is that there will not be much competition for such molecules. Could be worth asking in concall.

Also another news announced yesterday.
This is to inform the exchange that our Associate Company, Rhizen Pharmaceuticals SA has released a Press Release announcing that the USFDA has granted Fast Track Designation for RP6530 (tenalisib

(Gaurav Chandak) #422

Alembic Pharmaceuticals Limited today announced that the company has received
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New
Drug Application (ANDA) Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product
(RLD), Wellbutrin® Tablets, 75 mg and 100 mg, of GlaxoSmithKline LLC. Bupropion
Hydrochloride Tablets USP, 75 mg and 100 mg is indicated for the treatment of
major depressive disorder.
Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg, have an estimated
market size of US$ 37 million for twelve months ending December 2017 according to
Alembic now has a total of 72 ANDA approvals (64 final approvals and 8 tentative
approvals) from USFDA.

(Harshit Goel) #423

Alembic Pharma FY18 Annual Report Notes.

  • International Generics = 38% (77% = USA, Others = 23%), Branded = 41% (chronic = 67%, acute = 33%), API = 21%.
  • Export = 56%, domestic = 44%.
  • 16% in R&D, 900 employees in R&D.
  • 26 ANDA filed in USA this year, total cumulative filings at 132.
  • work on our new oral solid dosage facility at Jarod is on track and will be completed by H2 2019.
  • We have been on a steady path of expanding our capabilities and are in the course of creating major facilities of `1,100 Crores. Our upcoming manufacturing units for general injectables and oncology injectables are on track and should be ready for exhibit batches by H1 2019.
  • Completed acquisition of Orit Labs in USA. Our acquisition of Orit Laboratories LLC will increase our breadth and capabilities in the US with a competent R&D team bringing complementary skill sets in soft gelatin based oral solids and oral liquids.
  • US front end crossed $ 100 miliion sales in the current year with a growth of 69%.
  • During the year under review, our following facilities were inspected and audited by USFDA:
    a) Bioequivalence located at Vadodara without any Observation.
    b) Formulation Facility at Panelav with three observations. None of the observations were related to data integrity or repetitive in nature. The Company submitted its response on the observations with USFDA.
  • Invested Rs. 200 cr. Aleor Dermaceuticals Ltd. through NCDs.

(Rohit) #424

Results announced :

• Net Sales for the quarter up 33% to Rs 863 crores against Rs 648 crores last
• Net Profit up 50% to Rs 98 crores from Rs 65 crores last year.

Operational Highlights for the quarter
International Business
• International Formulation business grew 25% to Rs 352 crores.
• ElR Received from the US FDA for Panpharm Formulation Facility.
• EIR Received from the US FDA for API Ill at Karakhadi.
• 3 ANDA approvals received during the quarter, Cumulative ANDA approvals
at 73 including 9 tentative approval.
• 3 ANDA filings during the quarter, Cumulative ANDA filings at 135.
• R&O spend at Rs 122 Crores, 14% of Sales.
India Formulations Business
• India formulations business grew 40% to Rs 331 crores as against Rs 236
crores last year.

So is this the revival of pharma again ? Regulatory hurdles clearing. Dollar is strong. Shall we expect the rally in pharma again ?

(Harshit Goel) #425

Alembic received approval for Bimatropost Opthalmic Solution. Estimated market size is USD 63 mn. Alembic is currently in litigation with Allergan for this product so the launch will depend on the outcome of litigation.


(Harshit Goel) #426

Latest Credit Rating Report ofAlembic Pharma by Crisil provides some good insights.

Key Points

  • Revenue remained flat in fiscal 2018 compared to the previous fiscal, on account of destocking in the first quarter before rollout of the goods and service tax (GST) in the domestic market and price erosion in the US market.
  • The operating margin, however, remained in line with expectation at 21%, led by cost-cutting measures and relatively lower R&D of 13% of sales.
  • Revenue is expected to grow 11-12% over the medium term, led by recovery in the domestic market and new product launches in the international segment, which will partially offset the pricing pressure in the US market.
  • The operating margin is likely to remain at about 19%, given the elevated R&D requirement (about 14% of sales) for building abbreviated new drug applications (ANDAs), particularly for specialised generics.
  • Revenue growth is expected to recover over the medium term with regular ANDA filings and product approval cycle improves with the implementation of the generic drug user fee amendment (GDUFA).
  • The company has large ongoing capex of Rs 1200 crore (commenced in fiscal 2016 and about 70% complete till fiscal 2018). With the project expected to be completed in fiscal 2019, the annual capex is expected to be about Rs 400 crore over the medium term.
  • In March 2018, the formulations facility in Panelav, Gujarat, received three observations under form 483; the company has responded to these.
  • In the domestic market, regulatory impact of drug price control order (DPCO) and ban on some Fixed Dose Combinations (FDC) has adversely affected revenue and profits in the past; and may continue to do so over the medium term.
  • The portfolio remains significant in the acute segment (50% of domestic formulation sales in fiscal 2018), with top five brands from it accounting for nearly 40% of domestic revenue. The significant revenue share from this slow-growing segment exposes the company to pricing pressure as many companies compete in a mature segment.