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Launch of Trastuzumab in US market offers a sizeable opportunity for Biocon & Mylan, says Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Biocon and Mylan have launched a cancer drug Trastuzumab in the United States. The size of the drug is USD 2.5 to 2.8 billion in the US market.

Biocon and Mylan have launched a cancer drug Trastuzumab in the United States. The size of the drug is USD 2.5 to 2.8 billion in the US market and Biocon is estimated to make USD 70 to 100 million in peak sales.

Speaking at length about this development Kiran Mazumdar Shaw, CMD of the company said they entered the US market after being the first to be approved but Amgen (pharma company) launched Trastuzumab at risk. Apart from Amgen there are two other approvals as well, she added.

“However, we believe that the space is still not crowded. We believe that this is a very important segment for us. The market dynamics are about ensuring access to this very important breast cancer drug and we believe that Mylan and Biocon are committed to this end and we believe that we are able to offer affordable access to this lifesaving breast cancer drug,” she added.

“We believe we will have a pretty major impact on this market opportunity and can get a sizeable share of the market despite 4 other competitors that we will have to contend with,” she further said in an interview with CNBC-TV18.

“We have a profit share arrangement with Mylan and we believe that the opportunity is sizeable for both Myland and Biocon,” she said, adding that they would be able to share more accurate estimates as they enter the market and see how they fair.

Not committing to any number, she said  there are estimates that analysts have assessed from the market size and market dynamics.

She said they got both the dosage forms of 440 and 150 mg, which puts them in a strong position to garner market share. “The 150 mg formulation is the dominant formulation, which Biocon has in terms of approval,” she added.

On biosimilars front, the CMD said, “This is our second biologics to be marketed or commercialized in the US. The first being Pegfilgrastim. So we do have a growing portfolio of biosimilar antibodies for cancer. The next being Bevacizumab. So as a company Mylan and Biocon are well positioned to be strong player in this whole oncology space.”

We have a significant presence in some of the among emerging markets for Trastuzumab , said Mazumdar Shaw.

Talking about their sales target of USD 1 billion for biosimilars  by FY22 she said, “At the moment we are very much on track. We believe that we can get even more confident once our products enter the markets and we see the kind of market share we are garnering, but at this point in time we remain confident of hitting that target.”

 

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It’s bull and bear case for Biocon: Analysts divided as flat performance of biologics business spooks market

Biocon

Biocon Limited has been in spotlight after announcing its fourth quarter results last week, as the stock lost around 10 percent. While the company reported a good but in-line set of numbers, it seems the street is spooked on the flat performance of the biologics business on a quarter-on-quarter (QoQ) basis and there are questions regarding the biosimilars business and its prospects.

To discuss the bull and bear case for Biocon, CNBC-TV18 spoke with market expert Prakash Diwan, who is bullish on the stock, and Vishal Manchanda, Pharma Analyst at Nirmal Bang Institutional Equities, who remains bearish.

Sharing his rationale for being bullish on the stock, Diwan says Biocon has always built high expectations and what is seen now is rationalisation of these expectations and hence the downward move, even though the Q4 numbers are not bad.

“Now we need to start factoring in all the launches they have had in the US, Europe and other markets, which will give enough visibility. Other triggers are turnaround in the Malaysian unit and expansions with new alliances. It would not be unreal to expect Biocon to continue getting valued richly although competition is likely to be severe. I would still believe it would continue to be higher in terms of valuations than conventional pharma companies,” he adds.

However, Manchanda pointed out that in the next 12 months there could be 4-5 other players entering the Neulasta market, and there could be price erosion to the tune of 70-80 percent. Biocon was lucky to have got the opportunity to launch Neulasta as first player. The question is whether at those prices the market will allow them to make profits? So will it be as attractive in terms of profitability as it is now?

Similarly, although the company has approval to launch Trastuzumab, there are three other players with approval and another is waiting for clearance. “Moreover, Trastuzumab will be a difficult opportunity to execute because it is an oncology molecule and acceptance will be gradual. So one will have to factor the slow ramp-up,” he said.

Overall, the valuations built-in are for a better scenario, Manchanda observed.

Biocon is slated to take on competition by widening its product mix, said Diwan, adding that he does not expect the company to disappoint on earnings growth although multiples may not be as punchy as they have been traditionally. The price target for the stock could be around Rs 750-770 in the next 12-18 months, he noted.

 

Biocon Q3 earnings today: Here’s what to expect

CESC

Indian biopharmaceutical company Biocon is set to report its third quarter results on Thursday. Here are key factors to watch out for:

  • It is expected to be a strong quarter for the company.
  • The revenue is likely to grow around 30 percent.
  • Margin expansion of around 400 basis points seen, led by higher margin products. One basis point is a hundredth of a percentage point.
  • Profit is expected to see a growth of 79 percent.
  • Within the biosimilar business, the one thing which is going to drive growth will be the launch of Pegfilgrastim in the US, the cancer biosimilar.
  • Branded formulation segment is likely to follow biologics with strong growth of 20-25 percent.

Biocon expects growth in biologics from FY20-FY21 given launch pipeline

Biocon Kiran Mazumdar Shaw

Bengaluru-based biotechnology firm, Biocon, on Wednesday said company is expecting growth in biologics from FY20-FY21 given launch pipeline.

In an interview to CNBC-TV18, Siddharth Mittal, chief financial officer, said Biocon had a revenue of $36 million in the first quarter and guidance has been at $200 million for the fiscal year 2019.

“The current revenue base comprises of the products that we have been selling in many emerging markets and comprises of insulin, glargine and trastuzumab,” Mittal said.

“Our partner Mylan has launched pegfilgrastim in the US in Q2, which would also be a big growth driver for Q2 to Q4, and will add to the revenue growth,” Mittal added.

According to Mittal, Biocon expects operating margin to remain stable despite fluctuations in raw material prices from China.

Confident of clocking sales of over $200 million for biologics in FY19, says Biocon

Biocon Kiran Mazumdar Shaw

Kiran Mazumdar Shaw, chairperson and managing director, Biocon said we are confident of clocking sales of over $200 million for biologics in FY19.

Shaw said that Mylan-Biocon launched biosimilar pegfilgrastim in the US.

Talking about trastuzumab, she said, “The US approval has been obtained and Mylan is in preparation to launch it when it is possible because they have an agreement with Roche for launching of this product in the US and in Europe.”

She further said that our dossier for trastuzumab under review by the EU authorities.

“We expect to enter into the European Union and Australia by the end of this calendar year,” she further mentioned.

“R&D costs have come down to Rs 88 crore this quarter,” she added.

She also said that the decisions on Lupin tie-up was a commercial decision

 5 Minutes Read

Regulator says Samsung Biologics breaches accounting rules

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

South Korean regulator says Samsung Biologics Co. has breached accounting rules in a preliminary finding that could deal a big blow to the company and other Samsung affiliates if finalized.

South Korean regulator says Samsung Biologics Co. has breached accounting rules in a preliminary finding that could deal a big blow to the company and other Samsung affiliates if finalized.

Financial Supervisory Service said Wednesday it has wrapped up its one-year probe into Samsung Biologics and notified the company of the violation. It declined to confirm details of its interim conclusion pending a review at the Financial Services Commission. The notification gives Samsung Biologics a chance to defend itself.

Samsung Biologics is denying the accounting breaches.

Despite its defense, its stock price tanked, finishing 17.2% lower.

At stake is whether Samsung Biologics accurately evaluated the value of its affiliate Samsung Bioepis before its initial public offering in 2016.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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