SYNGENE

Corrects deal value in headline, paragraph 1 to $36.5 million, from $50 million

March 10 (Reuters) - India's Syngene International on Monday said it has acquired its first biologics facility in the United States from Emergent Manufacturing Operations Baltimore, a unit of Emergent BioSolutions EBS.N, for $36.5 million.

The contract research firm's acquisition of the facility aligns with broader industry efforts to reduce dependence on China by expanding capabilities in other regions.

The facility, which the contract research firm said is strategically located near key biotech hubs in the Northeast U.S., is expected to be operational for client projects from the second half of 2025.

This acquisition, expected to close in March 2025, will boost Syngene's total single-use bioreactor capacity to 50,000 liters from 20,000 liters, enhancing its capabilities in large molecule discovery, development and manufacturing services.

"In the short term, we expect minor dilution of operating margins as a result of costs to be incurred in this facility," Deepak Jain, Syngene International's chief financial officer, said.

India's contract research development and manufacturing organisation sector has the potential to grow seven-fold to $22 billion-$25 billion by 2035, according to a report by Boston Consulting Group.

(Reporting by Yagnoseni Das in Bengaluru; Editing by Vijay Kishore)

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March 7 (Reuters) - Syngene International Ltd SYNN.NS:

• PENALTY PROCEEDINGS FOR 32.6 MILLION RUPEES DROPPED

Source text: ID:nBSE27YvXm

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Corrects paragraph 14 to say India has "committed" not "invested" $2.86 billion

By Rishika Sadam, Kashish Tandon and Bhanvi Satija

HYDERABAD Feb 27 (Reuters) - India's contract drug makers have urged the government to remove regulatory hurdles and grant faster clearance to vital raw material imports at a time when many global pharmaceutical firms are counting on the nation to reduce their reliance on China.

India's Contract Research Development and Manufacturing Organisation (CRDMO) sector is at an inflection point, with the potential to grow seven-fold to $22 billion-$25 billion by 2035, according to a report by Boston Consulting Group.

Globally, the market stands at $140 billion-$145 billion.

"The government has to understand that this industry has potential, if not scale, right now," Krishna Kanumuri, CEO and managing director at Sai Life Sciences SAIE.NS, said at an event earlier this week.

India's contract drug manufacturers have gained from global companies' efforts to diversify their supply chain after the pandemic and a U.S. bill that would prohibit federal contracts with certain Chinese biotech firms on national security grounds.

However, India's policies are yet to play catch-up.

For instance, prolonged approval times and regulatory demands tied to certain raw material imports meant Indian firms often require eight to 15 days to initiate projects, while their Chinese peers could do it within three days, according to Vikash Aggarwala, MD and Partner at BCG's healthcare practice.

Industry insiders pushed for more business-friendly policies in the world's fifth-largest economy, which is heavily dependent on China for drug-related raw materials.

Piramal Pharma's PIRM.NS Chairperson Nandini Piramal lamented the lack of customs warehouses at the right locations and related logistics costs, a dearth of cold storage units, and delays tied to the clearance of certain raw material imports.

"All of those, I think, add more friction to the ease of doing business," Piramal told Reuters.

Some others highlighted the delay in approvals due to the lack of a centralized, digital, single-window clearance system.

Syngene's SYNN.NS CEO-designate Peter Bains said the "friction and delay" could be compressed, highlighting it was "a disadvantage that India has against other jurisdictions".

India's health and finance ministries did not respond to Reuters requests seeking comment.

The country, which offers cheap labour and a large talent pool, has already committed over $2.86 billion in the local biotech industry, according to the BCG report. But industry insiders are urging for more.

"I would really pitch for a CRDMO park... with policies where you don't have to go and get permissions from the local drug controller for making changes, where there are easy export and import capabilities," Aragen Life Sciences CEO Manni Kantipudi said.

($1 = 87.3900 Indian rupees)

(Reporting by Rishika Sadam, Kashish Tandon and Bhanvi Satija; Editing by Dhanya Skariachan and Janane Venkatraman)

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Feb 26 (Reuters) - Syngene International Ltd SYNN.NS:

• SYNGENE INTERNATIONAL - TAX DEMAND ORDER REDUCED TO 102 MILLION RUPEES

Source text: ID:nNSEbX1r3H

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Feb 10 (Reuters) - Syngene International Ltd SYNN.NS:

• JONATHAN HUNT STEPS DOWN AS MD & CEO OF SYNGENE

• PETER BAINS APPOINTED CEO DESIGNATE OF SYNGENE

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BENGALURU, Jan 23 (Reuters) - Diary of India economic, corporate events on Jan. 23

ECONOMIC, CORPORATE .BSE500 EVENTS:

NTS - 'No time scheduled', AMC - 'After market close'

(Compiled by Bengaluru Newsroom)

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Jan 14 (Reuters) - Syngene International Ltd SYNN.NS:

• AGGREGATE TAX AMOUNT UNDER GOVERNMENT SCHEME TO BE PAID IS 94.7 MILLION RUPEES

• PAID 15.3 MILLION RUPEES TAX UNDER PROTEST, BALANCE TO BE PAID WITHIN 15 DAYS

Source text: ID:nBSE4gwqJ2

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Adds details paragraph 2 onwards

Dec 31 (Reuters) - Indian contract drugmaker Anthem Biosciences filed for a 33.95-billion-rupee ($397 million) initial public offering, draft papers showed on Tuesday, at the fag end of what has been a red-hot year for companies listing on the stock market.

Anthem, whose services include early-stage drug discovery and drug efficacy testing, said private equity firm True North and drugmaker DavosPharma are among investors who will sell shares in the IPO.

The company will not sell any shares and it did not give any other details on the offering.

The Indian IPO market has been bustling this year, with over 300 companies having raised $17.5 billion as of mid-December, more than double the amount raised last year, LSEG data showed.

That gives it the top spot globally in terms of proceeds and volumes, according to consultancy firm KPMG.

Anthem, which began operations in 2007 and has two manufacturing facilities, is also going public at a time when global drugmakers are turning to India and other markets to limit their reliance on Chinese contractors.

Begaluru-based Anthem also makes active pharmaceutical ingredients (API), which are the main component of a drug, as well as dietary supplements and probiotics.

It competes with the likes of Syngene International SYNN.NS, Divi's Laboratories DIVI.NS and newly-listed Sai Life Sciences SAIE.NS among Indian API makers.

($1 = 85.5720 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Savio D'Souza)

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Dec 10 (Reuters) - Biocon Ltd BION.NS:

• SELLS 8 MILLION EQUITY SHARES OF SYNGENE INTERNATIONAL THROUGH BLOCK DEAL

• SHAREHOLDING IN SYNGENE NOW AT 52.46%

• RECEIVES APPROXIMATELY 6.86 BILLION RUPEES FROM SALE

Source text: ID:nBSE5j8PXC

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Dec 5 (Reuters) - Syngene International Ltd SYNN.NS:

• GOT ORDER MODIFYING TAX DEMAND TO 25.9 MILLION RUPEES

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Oct 23 (Reuters) - Syngene International Ltd SYNN.NS:

• RESIGNATION OF CFO SIBAJI BISWAS

• RESIGNATION OF SIBAJI BISWAS, EXECUTIVE DIRECTOR AND CFO

• APPOINTMENT OF DEEPAK JAIN AS CHIEF FINANCIAL OFFICER

• SEPT-QUARTER CONSOL PROFIT 1.06 BILLION RUPEES

• SEPT-QUARTER CONSOL REVENUE FROM OPERATIONS 8.91 BILLION RUPEES

Source text for Eikon: ID:nNSE26tD5y

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Oct 1 (Reuters) - Syngene International Ltd SYNN.NS:

• GOT TAX REFUND ORDER FOR 136 MILLION RUPEES

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July 24 (Reuters) - Syngene International Ltd SYNN.NS:

• SYNGENE INTERNATIONAL LTD JUNE-QUARTER CONSOL PROFIT 757 MILLION RUPEES

• SYNGENE INTERNATIONAL LTD JUNE-QUARTER CONSOL REVENUE FROM OPERATIONS 7.9 BILLION RUPEES

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April 24 (Reuters) - Syngene International Ltd SYNN.NS:

• RE-APPOINTMENT OF JONATHAN HUNT AS MD AND CEO

• FINAL DIVIDEND OF 1.25 RUPEES PER SHARE

• SYNGENE INTERNATIONAL MARCH-QUARTER CONSOL PROFIT 1.89 BILLION RUPEES VERSUS PROFIT 1.79 BILLION RUPEES

• SYNGENE INTERNATIONAL MARCH-QUARTER CONSOL REVENUE FROM OPERATIONS 9.17 BILLION RUPEES VERSUS 9.94 BILLION RUPEES

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** Shares of contract research firm Syngene International SYNN.NS up 2.1% and pharmaceuticals firm Neuland Laboratories NEUL.NS up 4.8%

** Goldman Sachs initiates stocks with a 'buy' rating, sets street-high PTs of 875 rupees for SYNN and 9,100 rupees for NEUL; highlights improving funding for biotech, capacity ramp-up and new contract wins

** Brokerage believes India's share in global contract research/drug manufacturing will rise as companies reduce dependence on China; lists SYNN, NEUL as its top picks in sector

** "Any progress" on U.S. bill that prohibits federal agencies from contracting with China biotech companies/service providers, "could bring in disproportionate benefits" to NEUL - Goldman

** Meanwhile, shares of Laurus Labs LAUL.NS down 1.7% after brokerage initiates stock with "sell"

** NEUL up 23.5% so far this year, vastly outperforming LAUL's 5% rise and SYNN's 8.9% growth

(Reporting by Nandan Mandayam in Bengaluru)

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March 26 (Reuters) - Syngene International Ltd SYNN.NS:

• GOT 3 ORDERS SEEKING TAX AND INTEREST TOTALLING 120.9 MILLION RUPEES

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Updates with additional company comments in paragraphs 4 and 6

By Rishika Sadam and Leroy Leo

HYDERABAD, Feb 27 (Reuters) - U.S. drugmaker Bristol Myers Squibb BMY.N aims to expand its research and development presence in India and expects its newly inaugurated Hyderabad facility to become its largest unit outside the U.S. by 2025, CEO Christopher Boerner said on Tuesday.

The $100-million facility, inaugurated by Boerner on Monday, is expected to employ over 1,500 employees and will be used to enhance its drug development through the use of digital technologies and artificial intelligence, he said in his keynote speech at the BioAsia conference.

Bristol Myers also operates a research and development centre in Bengaluru in partnership with the Biocon Group's BION.NS Syngene International.

The India unit is participating in 17 clinical trials for testing new therapies for cancer, blood disorders and heart diseases among others, the cancer-focused drugmaker told Reuters.

Bristol Myers is yet to launch its cancer cell therapies Abecma and Breyanzi in the country, but its other cancer drugs such as nivolumab and ipilimumab are sold under the brand names Opdyta and Yervoi.

When asked about Bristol Myers's plans to launch or seek approval for its cell therapies in India, a spokesperson said that the company could not comment on its discussions with regulatory bodies.

The company is also developing next-generation cell therapies for autoimmune diseases such as multiple sclerosis and plans to use AI technologies to accelerate the development, Boerner said, adding that it plans to make these more widely available, including in markets such as India.

Bristol Myers expects its top-selling drugs such as blood thinner Eliquis and cancer immunotherapy Opdivo to lose patent protection in key markets later this decade and announced a string of deals late last year to restock its drug development pipeline.

(Reporting by Leroy Leo and Rishika Sadam in Hyderabad; Editing by Janane Venkatraman)

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** Shares of Biopharmaceutical co Biocon BION.NS down ~2.5% at 284 rupees

** Jefferies downgrades stock to "underperform" from "hold", keeps PT unchanged at 250 rupees

** Jefferies says downgrades will continue due to lack of launches in the biosimilars segment, weak FY25 outlook for unit Syngene SYNN.NS

** Given muted revenue growth and margin pressure, we believe free cash flow will remain weak for Biocon - Jefferies

** Last month, UBS downgraded SYNN to "sell" due to concerns on near-term revenue growth

** Avg rating of 17 analysts covering BION is "hold," their median PT is 272.50 rupees

** Biocon stock has been underperforming in the pharma index; since start of 2023 BION up ~8.5% vs a ~50% gain in Nifty Pharma Index .NIPHARM

(Reporting by Nishit Navin in Bengaluru)

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** Shares of contract research firm Syngene International SYNN.NS fall ~2% to 701.75 rupees

** Stock fell 2.3% on Tuesday after UBS downgraded rating to "sell" from "buy" and cut PT to 700 rupees from 875 rupees

** UBS' new PT lowest among seven analysts on SYNN, per LSEG

** Stock shed 4.4% in last two sessions

** Weak demand for the discovery and dedicated segments to put pressure on Syngene's near-term revenue growth - UBS

** Adds, concerns are rising with slow ramp-up of SYNN's API unit

** Avg rating of analysts at "hold"; median PT is 750 rupees - LSEG data

** Stock rose 20% in 2023, snapping two consecutive years of decline

(Reporting by Kashish Tandon in Bengaluru)

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Jan 10 (Reuters) - Syngene International Ltd SYNN.NS:

• ASSESSING OFFICER ISSUED PENALTY NOTICE TOWARDS DISALLOWANCE AMOUNTING TO 1.3 MILLION RUPEES

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Dec 1 (Reuters) - Syngene International Ltd SYNN.NS:

• CONCLUDES ACQUISITION OF BIOLOGICS MANUFACTURING FACILITY FROM STELIS BIOPHARMA

• ACQUISITION OF UNIT 3 BIOLOGICS MANUFACTURING FACILITY CONCLUDED AT REVISED GROSS VALUE OF 6.17 BILLION RUPEES

• REDUCTION IN GROSS VALUE REFLECTS RETENTION OF EQUIPMENT NOT CURRENTLY INSTALLED IN FACILITY BY STELIS BIOPHARMA

• ACQUISITION WILL ADD 20,000 LITRES OF INSTALLED BIOLOGICS DRUG SUBSTANCE MANUFACTURING CAPACITY FOR SYNGENE

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By Maggie Fick, Andrew Silver and Rishika Sadam

LONDON/SHANGHAI/HYDERABAD, Nov 27 (Reuters) - Drugmakers are seeking to limit their reliance on Chinese contractors who produce drugs used in clinical trials and early-stage manufacturing, a move that is benefiting rivals in India, according to interviews with 10 industry executives and experts.

China has for nearly 20 years been the preferred location for a range of pharmaceutical research and manufacturing services due to the low cost and speed offered by contract drugmakers there.

That relationship largely held firm despite a U.S.-China trade war under the Trump administration and supply chain havoc experienced by other industries during the COVID-19 pandemic. But increasing tensions with China have prompted more Western governments to recommend that companies "de-risk" supply chains from exposure to the Asian superpower.

That is leading some biotech companies to consider using manufacturers in India to produce active pharmaceutical ingredient (API) for clinical trials or other outsourced work.

"Today you're probably not sending an RFP (request for proposal) to a Chinese company," said Tommy Erdei, global co-head of healthcare investment banking at Jefferies. "It's like, 'I don't want to know, it doesn't matter if they can do it for cheaper, I'm not going to start putting my product into China'."

Dr Ashish Nimgaonkar, the founder of Glyscend Therapeutics, a U.S.-based biotech firm testing treatments for type 2 diabetes and obesity in early trials, agreed. "All of the factors over the past several years have made China a less attractive option for us," he said.

Nimgaonkar told Reuters that when Glyscend issues an RFP later in the development stage of the medicines it has in trials, Indian contract development and manufacturing organisations (CDMOs) would be preferred over Chinese ones.

Four of India's largest CDMOs - Syngene SYNN.NS, Aragen Life Sciences, Piramal Pharma Solutions PIRM.NS, and Sai Life Sciences - told Reuters they have this year seen increased interest and requests from Western pharma companies, including major multinationals.

Sai declined to comment on profit growth but said sales have grown 25%-30% in recent years. The other companies said they reported strong profit growth in the most recent quarter.

Top executives at the firms said some customers want to add India as a second source, in addition to China, for manufacturing. Others are seeking to leave China and even making requests to originate supply chains in India.

The full benefit for these Indian manufacturers will not be immediate, said Peter DeYoung, CEO of Piramal Pharma Solutions.

It will take time for treatments in early development to make it to the market, when contracts would become more lucrative for outsourcing firms like his, he said.

Chinese CDMOs are established makers of biologic drugs, which require a higher threshold of regulatory approval than conventional medicines, said Helen Chen, Greater China Managing Partner at L.E.K. Consulting in Shanghai.

Hiring a new firm for complex work such as biologic manufacturing can take three to five years, she added. "It's really not something that (companies) just pick up and move like shoes."

STRONG GROWTH

India is seeking a bigger foothold in the pharma services sector to boost sales and reputation for its $42 billion pharmaceuticals industry.

But concerns over lax oversight persist. Nimgaonkar said Indian CDMOs need to do more to ensure their reputation on quality standards matches Western and Chinese ones.

In February, the U.S. Food and Drug Administration (FDA) warned against using an eye drop made in India linked to the outbreak of a drug-resistant bacteria in the United States that caused one death.

India-based research firm Mordor Intelligence estimates revenue from India's CDMO industry at $15.6 billion this year compared to $27.1 billion in China. But it estimates revenues from India's industry will grow, on average, at more than 11% annually over the next five years, compared to about 9.6% for China.

The Indian CDMOs told Reuters that their facilities are routinely inspected by the FDA. An FDA spokesperson declined to comment.

Piramal Pharma has this year received requests from clients for "backward integration to India", which means that even the most basic raw materials are sourced from the country instead of China, said DeYoung. Piramal buys about 15% of its raw materials from China but is trying to reduce that.

Sai Life Sciences said it almost doubled manufacturing capacity since 2019 and is adding another 25% in the next year or so to meet demand.

Ramesh Subramanian, chief commercial officer of Aragen, a privately-owned Indian firm that has grown from 2,500 to 4,500 employees in the past five years, said revenue growth of 21% last year was partly driven by new contracts with Western biotech firms. Aragen counts seven of the 10 biggest pharma companies as clients, he said, declining to name them.

The shift is particularly evident in drug discovery work for conventional pharmaceuticals.

"New biotechs are deciding to put eggs in both the Indian and China baskets from the start," Subramanian said.

(Reporting by Maggie Fick in London, Andrew Silver in Shanghai and Rishika Sadam in Hyderabad;
Editing by Michele Gershberg and Catherine Evans)

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Oct 17 (Reuters) - Syngene International Ltd SYNN.NS:

• INDIA'S SYNGENE INTERNATIONAL SEPT-QUARTER CONSOL PROFIT 1.17 BILLION RUPEES VERSUS PROFIT 1.02 BILLION RUPEES

• SYNGENE INTERNATIONAL SEPT-QUARTER CONSOL REVENUE FROM OPERATIONS 9.1 BILLION RUPEES VERSUS 7.68 BILLION RUPEES

Source text for Eikon: ID:nNSE8FXmq9

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Adds details in para 2-4, background in 5

BENGALURU, Sept 18 (Reuters) - Indian drugmaker Biocon Ltd BION.NS on Monday appointed Peter Bains as the group's chief executive officer, effective immediately.

Bains, who was named as an independent director of the Biocon board in December last year, stepped down on Monday to assume the top charge, the company said in a statement.

"Peter has a unique fit and profile for the role having ... a comprehensive understanding of the Biocon Group ... having led Syngene for five years, (and) taking it through its very successful IPO in 2015," said Kiran Mazumdar-Shaw, Biocon group chairperson.

Bains, the first-ever group CEO, will report directly to Mazumdar-Shaw, the statement added.

A graduate of the University of Sheffield in the UK, Bains was associated with Biocon's research unit Syngene International SYNN.NS from 2010 to 2016, according to the company website.

He was named Syngene's CEO in April 2015, before retiring from the post a year later.

(Reporting by Hritam Mukherjee in Bengaluru; Editing by Shailesh Kuber and Sohini Goswami)

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** Shares of Syngene International SYNN.NS rise as much as 6.7% to a record high of 813 rupees

** Co on Wednesday reported June-qtr profit of 753 mln rupees ($9.18 million) versus profit 732 mln rupees year ago

** Rev from ops rose 11% to 7.16 bln rupees during the qtr

** More than 2.5 mln shares change hands by 10:40 a.m. IST vs 5.2x 30-day avg of 478,994 shares

** SYNN trading above its moving average convergence divergence line (MACD), indicating bullish sentiment

** Analysts covering the stock on average have a "strong buy" rating; median PT is 750 rupees - Refinitiv data

** Stock up 30.3% YTD up to last close

($1 = 81.9975 Indian rupees)

(Reporting by Ashna Teresa Britto in Bengaluru)

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July 26 (Reuters) - Syngene International Ltd SYNN.NS:

• JUNE-QUARTER PROFIT 753 MILLION RUPEES VERSUS PROFIT 732 MILLION RUPEES

• JUNE-QUARTER REVENUE FROM OPERATIONS 7.16 BILLION RUPEES VERSUS 6.45 BILLION RUPEES

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Further company coverage: SYNN.NS

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** Shares of Strides Pharma Science SRID.NS fall as much as 7.2% to 448.7 rupees, biggest pct loss since May 25

** Co on Tuesday reported that unit Stelis Biopharma enters into binding term sheet with Syngene International SYNN.NS to divest its Unit 3 multi-modal facility situated at Bengaluru, India

** Syngene to acquire Unit 3 on a slump sale basis for gross consideration of 7.02 bln rupees ($85.43 million)

** More than 2.1 mln shares change hands by 01:30 p.m. IST vs 1.6x 30-day avg of 1.3 mln shares

** Stock up 38.2% YTD up to last close

($1 = 82.1725 Indian rupees)

(Reporting by Ashna Teresa Britto in Bengaluru)

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** Shares of Syngene International Ltd SYNN.NS rise as much as 5.70% - biggest intraday gain in over six months - to 660 rupees

** Contract research company reports 21% year-on-year rise in consolidated profit to 1.79 bln rupees in March quarter

** Revenue from operations up 31% YoY, core profit rises 26% to 3.14 bln rupees rupees in Q4

** For the full financial year 2023, SYNN has reported its highest absolute rise in revenue and core profit in five years, co says in investor presentation

** Trading volume at 1.61 mln shares as of 9:50 a.m. IST, nearly quadruple the 30-day avg, most active trading session since the union budget on Feb. 1

** Relative strength index of the stock is 76, suggesting stock may be overbought - Refinitiv data

** Of the eight analysts tracking SYNN, seven maintain "buy" and one suggests "hold"; median TP is 723.50 rupees - Refinitiv data

(Reporting by Bharath Rajeswaran in Bengaluru)

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April 26 (Reuters) - Syngene International Ltd SYNN.NS:

• MARCH-QUARTER CONSOL PROFIT 1.79 BILLION RUPEES VERSUS 1.48 BILLION RUPEES

• MARCH-QUARTER CONSOL REVENUE FROM OPERATIONS 9.94 BILLION RUPEES VERSUS 7.58 BILLION RUPEES

• FINAL DIVIDEND OF 1.25 RUPEES PER SHARE

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