Tag: Sun Pharma

Pharma Q4FY24 earnings preview | Robust US performance expected to drive revenue growth

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

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Pharmaceutical companies are likely to report around 12-14% healthy year-on-year (YoY) revenue growth and as much as 26-27% earnings before interest, taxes, depreciation, and amortisation (EBITDA) growth for January-March 2024 as a steady quarter in the US offsets a seasonally weak domestic market.

The US markets could grow as much as 22% YoY, higher than the four-quarter growth average of around 17-18%.

This expansion will be aided by easing price pressure and sales of key drugs, especially continued sales from the blockbuster cancer drug Revlimid generic.

Here’s how the US market sales could look like company-wise

• Dr Reddy’s Laboratories (DRL) could see around 5% quarter and quarter (QoQ) growth, which would be led by over $100 million from Revlimid generic and aided by the integration of the main portfolio.
• Zydus is expected to grow over 20% QoQ led by Revlimid generic again, which could add as much as $50 million for the company, according to some estimates.

• Cipla’s sales could be tempered due to a loss of market share for the respiratory drug Albuterol.
• Sun Pharma could see around 2% QoQ growth led by their speciality portfolio of drugs, which has been doing well consistently.

• Lupin will benefit from the inhaler Spiriva generic driving around a 4% QoQ growth for the company in the US.

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Domestic market for Lupin is likely to grow around 10-11% driven by sales of chronic drugs and a recovery in acute therapy drugs.

JB Chemicals and Mankind are likely to outperform with an over 20-25% growth in the domestic market.

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Margins will be aided by niche products in the US and lower operational costs. Estimates are margins could expand by as much as over 250 basis points.

Also, watch for higher CDMO sales QoQ pushing up earnings for Divis Laboratories as well as Laurus Labs.

Margin improvement and commentary will be key for both these companies as the Street will watch for cues on big orders from multinational companies (MNCs) and progress on opportunities such as GLP 1 drugs.

Lastly, analysts will watch out for an update on US pricing from Aurobindo, Lupin and others, pending US FDA issues for Cipla, Sun Pharma, Biocon and commentary on fundraising from the likes of Biocon.

Also Watch | Vishal Manchanda, Pharma Analyst at Systematix Group, talked on CNBC-TV18 about what to expect in the pharmaceutical sector for the Q4 of FY24.

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Sun Pharma gets Australian regulator’s nod for acne drug Winlevi

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

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Sun Pharmaceutical Industries Ltd on Tuesday announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for its clascoterone cream, Winlevi. Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Winlevi will be available in Australia from June 2024, the company said in a regulatory filing on March 19.

As stated by Hellen de Kloet, Business Head – Western Europe, Australia and New Zealand, Sun Pharma, “Winlevi is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia. Winlevi’s novel mechanism of action will be a welcome addition to the physician’s toolkit while treating acne.”

“We are very pleased that Winlevi will soon be available to patients in Australia. This is another achievement in the mission of Cosmo and Sun Pharma to improve the lives of patients affected by skin conditions,” said Diana Harbort, President of the Dermatology Division of Cosmo.

Shares of Sun Pharmaceutical Industries Ltd settled 1.37% higher at ₹1,569.35 apiece on the NSE on Monday. The stock has gained 25% so far in 2024.

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Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violation

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

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Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the US market due to manufacturing practices norms deviations, according to the US health regulator.

The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Sun Pharmaceutical Industries Inc. is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) respectively of the medication due to Current Good Manufacturing Practice regulations (CGMP) deviations, it stated.

“Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment,” the USFDA stated.

The affected lot was produced at Sun Pharma’s Dadra-based plant for Memphis-based Northstar Rx LLC, the US regulator noted.

Febuxostat is used to lower uric acid levels in people with gout.

As per the USFDA, the company has initiated the Class II nationwide (US) recall on March 4 this year.

As per the USFDA, a class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Sun Pharma is one of the leading generic pharmaceutical companies in the US. The US generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.

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Sun Pharma growth prospects intact; share gets ‘Buy’ call as positive earnings surprise continue

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

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Shares of Sun Pharmaceutical Industries Ltd were trading lower on Thursday even after the drugmaker surprised the Street positively, yet again. Sun Pharma delivered robust performance in domestic formulation (DF), specialty portfolio, US generics as well as the ROW market. This was partially offset by subdued show in emerging markets for the quarter. The R&D expenditure remained lower than earlier guidance, partly driving better profitability for the quarter.

Analysts at several brokerage firms have reaffirmed their ‘Buy’ call on the Sun Pharma stock. BofA raised the target price of the stock while reiterating a ‘Buy’ view on the stock. Meanwhile, Citi, Motilal Oswal and Nuvama remain upbeat on Sun Pharma’s growth prospects and maintain a ‘Buy’ rating.

Domestic brokering firm Motilal Oswal remains positive on Sun Pharma, given its position as a leading company establishing a robust specialty franchise in developed markets and driving better-than-industry growth in branded generics markets.

The brokerage has raised their earnings estimates for FY25 and FY26 by 4% and 5%, factoring superior execution in global specialty sales, revival in growth prospects in Taro, and an industry-beating growth in the branded generics DF market.

Accordingly, Motilal has arrived at a price target of ₹1,635 per share and reiterated its ‘Buy’ view on the stock.

JM Financial said that Sun Pharma’s annual operating cash flows of over $1 billion and potential access to Taro’s rich cash reserves, if the offer sails through, creates room for bolder and bigger bets in the specialty segment (such as Concert).

The key focus area, as per the brokerage, remains derma and eye-care in the US. It expects Sun’s specialty sales to sustain double-digit growth momentum given Ilumya’s upward trajectory and Deuruxolitinib launch likely next fiscal.

Also, the Street seems to be underappreciating Sun’s potential in generics — it has a robust pipeline and resolution of site issues could be a positive trigger, JM Financial said in its post earnings stock review note.

Given the robust specialty outlook, domestic leadership, strong cash position and risk-appetite for large M&As, the brokerage has assumed coverage with a ‘Buy’ rating and a target price of ₹1,580 a share.

BofA maintains a ‘Neutral’ stance on the Sun Pharma stock and hiked its target to ₹1,440 from an earlier target of ₹1,370 per share. The brokerage said that the company’s US And India growth was positive and the Q3 earnings were in-line with its estimates. There were pulls and pushes in the specialty segment with drugs ‘Ilumya’ remaining strong while ‘Winlevi’ missing spark. Earning drivers have been factored-in in its valuation.

Citi has a target price of ₹1,640 per share on the counter, led by 2-5% increase in earnings, multiple raise and roll forward. The brokerage believes the company’s margin outlook to be strong.

However, the global brokerage expects a reversal in some factors, operating leverage in specialty and low concentration in the US.

On Thursday, the stock settled 0.76% lower at ₹1,407.65 apiece on the NSE.

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Sun Pharma Q3 Results: US formulation sales up 13%, margin beats estimates

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

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India’s largest drug manufacturer Sun Pharma Ltd. reported US formulation sales of $477 million for the October-December quarter, it said in an exchange filing. The number is 13.2% higher compared to the same quarter last year.

The US formulation business comprises of 33% of Sun Pharma’s overall sales.

Sun Pharma’s US formulation sales are also inclusive of Taro Pharma, which had reported results earlier this week with net sales rising by 13% to $157 million.

Sun Pharma has recently signed a definitive agreement with Taro to acquire the remaining stake it does not own in its subsidiary, taking its total stake to 100%. Sun Pharma will acquire the remaining 21% stake at $43 per share.

The drugmaker reported a net profit of ₹2,524 crore, which was higher than the CNBC-TV18 poll of ₹2,381 crore.

Revenue in rupee terms stood at ₹12,381 crore, in-line with expectations of ₹12,207.4 crore. On a year-on-year basis, revenue grew by 10.1% from last year.

Earnings before Interest, Tax, Depreciation and Amortisation (EBITDA) grew by 15.8% to ₹3,477 crore, while margin of 28.2% was 200 basis points higher than the CNBC-TV18 poll of 26.2%. When compared to last year, margin expanded by 150 basis points.

Formulation sales in the Emerging markets declined by 2.3% from last year to $252 million. The decline was due to adverse currency movements. Emerging markets accounted for 17% of the overall sales.

Rest of the World markets grew 12.9% year-on-year to $214 million and comprised of 15% of the overall sales.

“We are keenly looking forward to EMA filing of Nidlegy in the coming months,” said Sun Pharma MD Dilip Shangvi. “Once approved, Nidlegy will significantly expand our onco-derm franchise in Europe,” he added.

“Numbers were expected to be good for Sun Pharma this time around. Their specialty, based on the numbers that we saw, they were looking very strong, although they have some setbacks on the generics in the US. And India growth was also strong based on the AIOCD data. So overall, seems to be a good set of numbers,” said Vishal Manchanda of the Systematix Group.

Shares of Sun Pharma are trading 3.7% higher at ₹1,422.5. The stock has risen 40% over the last one year.

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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

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

Sun Pharma shares rise 4% after strong set of earnings from Taro

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

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Shares of Sun Pharmaceutical Industries Limited rallied 4% to hit a record high of ₹1,420.85 apiece on the NSE in trade Monday (January 29) after its subsidiary Taro Pharmaceutical Industries reported better-than-expected numbers in the third quarter (Q3FY24).

Taro reported a profit of $20.2 million in Q3 as against a profit of $7.3 million in the corresponding quarter of last year. The company’s revenue rose 13% year-on-year to $157.14 million in the quarter under review.

Taro Pharma also clocked in an operating income of $15.83 million in the third quarter, compared to $1.3 million recorded in the same quarter of the previous fiscal. The firm’s margins came in at 10.8%.

The Sun Pharma’s Israel-based arm didn’t gave any significant details on reasons for its improvement.

According to brokerage Elara Securities, the synergies is likely to have started playing out as the buyout of minority shareholders approaches. It also said that Taro’s 70% EBITDA beat equals to 3% beat on consolidated EBITDA estimates for Sun Pharma when it reports its Q3 numbers.

Positive earnings from Taro Pharma is also expected to boost parent Sun Pharma’s consolidated earnings. The pharmaceutical major is slated to release its quarterly earnings on January 31, 2024.

This month, Sun Pharma said it will acquire the remaining 21.52% stake in Taro Pharmaceutical Industries for ₹2,891.7 crore.

The purchase of outstanding public shares will allow Sun Pharma to consolidate control over Taro. Sun Pharma currently owns 78.48% in Taro.

In the past, Sun Pharma had faced resistance from Taro’s minority shareholders in its bid to take full control over the company.

The deal comes as a culmination to nearly 17 years of back and forth to gain full control of the US-listed generic drugmaker which does most of its business in the United States and Canada.

Upon completion of the merger, which is expected to close in the first half of the year, Taro would become a privately held company and will be delisted from the New York Stock Exchange, the companies had said earlier.

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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

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

India may consider restricting fluoroquinolone antibiotics just like the UK did

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

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In response to recent restrictions introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) regarding fluoroquinolone antibiotics, Indian health regulators are evaluating the implications for the usage of these antibiotics within the country.

On January 22, the MHRA, which is responsible for regulating medicines and medical devices in the UK, issued a critical alert, specifying that fluoroquinolone antibiotics administered systemically (by mouth, injection, or inhalation) should only be prescribed when no other antibiotics are appropriate for use. “This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient,” the MHRA site says.

Sources revealed to CNBC-TV18 that Indian regulators are now considering whether to introduce a fresh warning for fluoroquinolones in line with the UK’s guidelines. They said India is considering adding “should only be prescribed when other recommended antibiotics have failed” as a caution.

Fluoroquinolones, a class of antibiotics approved to treat or prevent certain bacterial infections, include well-known brands such as Ciprofloxacin (Cipro), Gemifloxacin (Factive), Levofloxacin (Levaquin), Moxifloxacin (Avelox), and Ofloxacin (Floxin).

These antibiotics are commonly prescribed to address respiratory and urinary tract infections.

Several popular brands in India are associated with fluoroquinolones, including Cipla’s Norflox, Mankind Pharma’s Zenflox, Cipla’s Levoflox, Lupin’s Percin Tablet, Glenmark’s Zinox, Ipca Labs’ Normax, and Sun Pharma’s Zanocin.

The MHRA said it conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and has sought advice from the Commission on Human Medicines (CHM).

“The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects. The restrictions have been introduced following Yellow Card reports from patients who have experienced long-lasting or disabling reactions following the use of fluoroquinolones, in some cases prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions,” the MHRA said.

The Yellow Card scheme is a system for recording adverse incidents with medicines and medical devices in the UK.

The health agency says serious adverse reactions to fluoroquinolone antibiotics include tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects.

Presently, there are seven FDA-approved fluoroquinolones for systemic use available on the market, including Moxifloxacin, Ciprofloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, and Ofloxacin.

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

Sun Pharma to acquire remaining outstanding shares of Taro for ₹2,891 crore

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

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Taro Pharma, the US-based unit of India’s largest drugmaker Sun Pharma Ltd., has announced a merger agreement with the latter, under which, Sun Pharma, Taro’s controlling shareholder, will acquire all remaining outstanding shares of its subsidiary.

Sun Pharma will acquire the remaining 21.52% outstanding shares of Taro for a cash consideration of $43 per share, amounting to $347.73 million or ₹2,891.76 crore, based on the USD-INR exchange rate of January 18.

The acquisition price is a 48% premium to Taro’s closing price on May 25, 2023, which was Taro’s last trading day before Sun Pharma submitted its first non-binding bid and a premium of 58% to the volume-weighted average price of Taro’s shares during the 60 days prior to and including May 25 last year.

Taro’s shares ended Wednesday’s trading session at $41.28, almost at par with the proposed acquisition price.

The merger is subject to various closing conditions, including shareholder approval of at least 75% of the voting power of the company’s shares, including a majority of those shareholders other than Sun Pharma and its affiliates. Sun Pharma has also indicated that it is not willing to sell its shares to a third party or support any alternative transaction to the merger.

Post the merger, which is expected to close in the first half of 2024, Sun Pharma will take Taro private and its shares would no longer trade on the New York Stock Exchange.

Sun Pharma had first submitted a non-binding bid to acquire the remaining outstanding shares of Taro for a cash consideration of $38 per share or nearly $300 million. It had earlier proposed a reverse triangular merger for this move, under which Sun Pharma would form a Special Purpose Vehicle (SPV), which will then merge with and into Taro.

In December last year, Sun Pharma had increased its bid to acquire the remaining outstanding shares to the current $43. Sun Pharma currently owns 78.48% of Taro.

Sun Pharma Group CFO CS Muralidharan had told CNBC-TV18 in November last year that the company has a net cash balance of $1.9 billion on a group level and a special committee was looking into Sun Pharma’s offer to de-list Taro. He had further said that the company will look at Merger & Acquisition (M&A) opportunities if and when an opportunity arises.

Taro Pharma’s shares rose 1% in extended trading on Wednesday in the US.

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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

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

Sun Pharma gets non-exclusive rights to sell Kidney disease treatment drug in India

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

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India’s largest drugmaker, Sun Pharma Ltd. has signed a marketing and distribution agreement for distributing a second brand of Finerenone in India, it said in an exchange filing.

Finerenone, a patented medicine is used to reduce in heart failure in adult patients with chronic kidney disease associated with a type-2 diabetes mellitus.

Under the agreement, Sun Pharma has non-exclusive rights to market and distribute the second brand of Finerenone under the Lyvelsa brand name. The patented drug was launched by Bayer first in 2022 under the brand name Kerendia.

India has the second-highest number of people with diabetes after China. Over 40% of the patients with diabetes will develop chronic kidney disease, according to a study by The Indian Chronic Kidney Disease (ICKD).

A phase-III clinical trial program of Finerenone showed that it significantly reduced the risk of composite Cardio Vascular outcome by 14%.

Kirti Ganorkar, CEO of Sun Pharma’s India business said that the collaboration will provide patients access to a new treatment, which slows down the progression of chronic kidney disease and reduces the risk of kidney failure associated with Type-2 diabetes.

“Through our partnership with Sun Pharma, we are advancing Bayer’s commitment of making healthcare accessible to as many patients as possible. India has a high incidence of diabetes and associated renal and cardiac conditions,” said Shweta Rai, Country Division Head of Bayer’s Pharma business in South Asia.

In an interaction with CNBC-TV18 post its September quarter results, Group CFO CS Muralidharan said that the company has maintained its financial year 2024 revenue guidance.

Shares of Sun Pharma are trading 1.1% lower at ₹1,298.70. The stock has risen 25% over the last 12 months.

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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

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

Pharma Q3FY24 outlook: What the Street anticipates

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

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Pharmaceutical companies are anticipated to witness robust year-on-year (YoY) growth in the third quarter, with estimated sales growth of 20%. This positive trajectory is set to be fueled by traction in US generics and a strong performance in the domestic formulations market. Projections suggest that the earnings before interest, tax, depreciation, and amortisation (EBITDA) growth of around 15% will be driven by niche launches in US generics and the advantage of lower freight and input costs. The profit is estimated to grow at over 15% YoY supported by reduced depreciation and tax.

In the United States, a YoY growth of 7%-8% is expected for the quarter, propelled by a reduction in pricing pressure and increased traction in limited competition drugs. Company-specific predictions include a 15-16% growth for Lupin, led by the sales of the inhaler drug Spiriva generic. Cipla and Dr Reddy’s are expected to maintain steady YoY contributions, with Cipla potentially facing quarter-on-quarter (QoQ) sales pressure due to a loss in market share for their key drug, Albuterol.

Domestic formulations are poised for steady growth of 8%-10% YoY, supported by enhanced market representative productivity, focus on over-the-counter (OTC) products, and the introduction of niche products in the country. Torrent Pharma is likely to report strong growth of around 15%, Alkem around 10-11%, and Mankind could outperform with a growth exceeding 25%, driven by a low base and sustained volumes.

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Stock-specific updates include expectations of over 15% YoY sales for Divis Labs, with a focus on commentary regarding opportunities from GLP1 inhibitor drugs. Biocon’s biologics sales may grow by as much as 40% YoY, attributed to market share gain in existing products. Investors will closely watch for updates on USFDA from Sun Pharma, Cipla, Biocon, Glenmark, and Dr Reddy’s.

While valuations have experienced a strong run-up, analysts suggest that true outperformance in terms of earnings will determine stock performance. Nithya Balasubramanian, Director-Healthcare at Sanford Bernstein, notes that the pharmaceutical sector is expected to rebound after a relatively weaker second quarter (Q2), with companies like Mankind, Alkem, and Cipla likely to post stronger numbers in the third quarter of FY24, reflecting positively on their margins.

“Also, one of the names we are expecting to do well after the quarter reporting would be Cipla because valuations are relatively reasonable. Of course, Cipla also did well last year,” she told CNBC-TV18.

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Catch all the latest updates from the stock market here

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

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

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