Also I am not sure this news has been reported
FDA on 30th Aug approved the first gene therapy , which I had mentioned earlier CAR-T. This needs a very close watch as dynamics of oncology market could change in the next 5 years or even less. Right now only Novartis has the approval to sell it & I think only Michigan Hospital can use it as of now. The others in the fray are Juno / Kite Pharma (now part of Gilead ) etc.
Also I am not sure this news has been reported
Some Interesting information that I came across on oncology therapy that has approved by FDA.
T-cells are present in our blood and part of immune system - T-Cells have adaptive receptors - They can adapt according to the infection present in our body and help in destroying the infection. In case of cancer patients, the T-Cell is not able to adapt to the cancer cells.
The therapy changes the patients T-Cells “externally” according to the patients cancer cells.
Blood is drawn from a patient - T-Cells from his blood is separated and is enhanced with a receptor using external source - The external source is the receptor created by engineering a virus using patient’s cancer cells. This enhanced T-Cells are injected back into the patient. The receptors in the enhanced T-cells attach themselves to cancer cells - The cancer cells are attacked by our immune system and the cells are destroyed.
- This therapy requires engineering a virus with information about patients cancer cells.
Hence going to be unique for each patient and requires highly qualified minds to work on this.
- This therapy requires the patients T-Cells - Again unique and cannot be pre-processed and made readily available. It must be done on demand.
- Going to be very costly (Half a million $).
- Very very difficult to achieve scale since it requires qualified minds to work on each case.
Hence the work Shilpa Medicare is doing is not impacted by this therapy - If Shilpa is successful, they will be able to market the drugs for masses and make money.
Kite Pharma thats working a similar therapy as mentioned above was acquired for 10B $. Speaks about the potential in this space.
Disclosure: Not from medical background - Own Shilpa (~1% PF)
I am not sure if this has been reported or debated
For me this is an important milestone
USFDA commissioner Scott Gottlieb is involved in the implementation of 21st Century Cures act
"The cures act authorized USD 500 mio over 9 years to help FDA cover the cost of implementing the law-Drug & device companies could see quicker , less expensive paths to approval for new medical products & has highlighted the law’s “breakthrough device” designation and the new oncology centre of excellence which aims to boost anti-cancer initiatives"
I would suggest please read the initiatives by he new FDA commissioner-very positive
Discl: 100% of my PF
An interesting article on latest strides in fight against the cancer,Is Shilpa present in any of the new forays ?
I am unable to attend the AGM but would appreciate if forum members are attending. A few questions from my side
-When do they expect to get certification from USFDA on Jadcherla , assuming CAPA has been submitted
- Makindus got Orphan status for MI-100 in 2015-whats the update on Phase 3-have they been able to pursue it or still in the funding stage (understand the diminution taken)
- Reva Pharmachem has tied up with which Japanese Pharma company?
-Can they shed more light on thin strips oral delivery (Shilpa Therapeutics) & visibility on revenues over the next few years
- Koanaa-I believe is the marketing arm for Shilpa Onco in Europe , so where does Loba Finechemie (step down sub.) sit in this equation -both being managed by Dr. Erber
Any one attending AGM tomorrow?
Dear Fellow Boarders,
Source: Motital Report
Given the frequency of inspection within a year, do we have any visibility on the next inspection? Would it be safe in saying that the operations team at Shilpa has been doing good with USFDA?
One more point possibly to check during AGM!
Hi Guys, has anyone got the AGM notes?
Strong pipeline and forward integration to drive earnings (Motilal Oswal report)
- SLPA has filed five ANDAs till date in Oncology, taking cumulative filings to 28. With only two approvals till date, SLPA has a robust ANDA pipeline awaiting approvals.
- Of the 28 filings, 13 are own and 15 are partnered. SLPA intends to increase share of own filings – based on its R&D, SLPA plans to file 7-10 ANDAs and 6-10 DMFs per year over the next 2-3 years.
- From a pure API company, SLPA is in process of transforming itself and forward integrating toward formulations.
- SLPA has 17 marketing authorizations for the Europe market, and intends to file 7-10 per year for the next 2-3 years. SLPA is in the process of tying up with a marketing agency to launch products in Europe.
- With the PMDA-Japan approval in place for two products and the focused efforts toward the Japan market, SLPA has started supplying products to one of the top companies. This is commendable because the Japan market, where the gestation period is high, is difficult to enter.
- SLPA would be enhancing its R&D efforts by setting up one more lab in Bangalore. In addition, it would be setting up a transdermal patches manufacturing plant at Bangalore. SLPA would be spending INR150cr toward this over the next two years.
- Capex over the next two years is expected to be INR400cr. Of this, INR150cr would be spent toward a constructing facility at Hubli for biosimilars. SLPA would be spending incremental INR100cr toward expansion of the formulation facility at Jadcherla and INR50cr toward expansion of the API facility at Raichur. In addition to powder filling, liquid filling and lyophilization capability, SLPA would be adding capacity for pre-filled syringes and liposomes at Jadcherla.
USFDA Issued EIR to Shilpa Medi for their Jadcherla Unit.
Shilpa has formed a nice support line on long term charts. Considering current RSI and MACD also favorable for some more upside in short term ( Long term I have no doubts)
Disc : Invested
Another gene therapy for Cancer.
This is however not a benign treatment -there have been deaths post this treatment. Point taken that cancer treatment may be moving towards CAR-T & could question oncology products over the next 10 years-lets see how these treatments develop. Thank you for the update
New announcement - We hereby intimate you that Mr. Rajendra Dugar, Chief Financial Officer (CFO) will cease to be CFO w.e.f 31 Oct 2017.
No reason given for resignation.
Disc: Invested. No txn in past 30 days.
The elephant in the room-its subsidiaries & JV’s continue to haunt this company. Profits on standalone are up only due to inventory pile up that happened last quarter. I believe they need to change their way of reporting giving more details (like what Caplin does) or call for an conference call & explain the anomalies in the result
Dicl: Fully invested but not adding further
This is the second time in about a year that the CFO ceases to be in the role. Last one was in Aug-2016. Shilpa Medicare -Racing away on the Oncology API highway!
I stand corrected on my statement
I had an opportunity to speak to a Research house (cannot name it unfortunately)
The consolidated drop is on account of the transfer of Ursodeoxycholic acid manufacture for ICE (now being transferred to Raichem). The original transfer was 50% of the 100% pct business to this 50:50 venture. Currently a lot of stabilization is going on that transfer front (batch testing etc.) , hence the loss. Probably by end Q4 FY18 , the breakeven status could be obtained. This has in a way allayed a lot of my concerns. Please don’t take my word for the above & do your own investigation.
The original business of Urso was around 220 cr of which around 100 cr is going under this JV & rest will also be transferred over time (is what I understand) & this transfer requires batch stabilization report etc. ( a lot of pre-condition on moving the production transfer) which is impacting the bottom line. Otherwise this analyst feels that numbers are quite good & moving in the right direction, specially on EBITDA front. Also Jadcherla positive impact will be seen in Q4.
Finally a new CFO has been appointed.
Also I checked the prices of azacitidine injection (available on Bloomberg under drug index). The price is currently USD 1.657 per mg of the drug. The peak was in 2013 (5.744) clearly indicating intense competition
Capecitabine (Oral 500 mg) is now trading around USD 6.683 against 33.56 in 2014-classic price erosion.
Both drugs at all time lows since the index was constituted in 2006
My take is that Shilpa’s next big jump probably emanates from Japanese approvals
Q2FY18 results update by MO… Margins driven by superior product mix; remains aggressive in ANDA filings…
Strong growth in sales post adjusting for shift in business to JV: Sales fell 3.4% YoY to 200cr, but were better than our estimate of 190cr. The sales decline can be ascribed to the transfer of the CRAMS business to a JV (since 3QFY17). Excluding the impact of this transfer, sales growth stands higher at 24% (led by addition of formulations and healthy traction in Onco-API).
Superior product mix drives margins: Gross margin expanded 970bp YoY to 58%, led by a superior product mix and higher income from exhibit batches. EBITDA margin of 27.8% expanded at a lower rate due to higher R&D and other expenses. Loss in JV and higher tax led to a PAT decline of 12% YoY to 33.6 cr.
Stable US sales from approved products: SLPA had US formulation sales of ~20cr in 2QFY18 from two products. The company continued gaining market share in g-Vidaza. SLPA has filed eight ANDAs in 1HFY18, taking the total to 33 (increased from 28 in Q1FY18).