reports
MOSL: DR REDDY’ S LABS (Neutral)- Weak performance continues-All eye...
​Dr Reddy’ s Labs:Weak performance continues; All eyes on key launches(DRRD IN, Mkt Cap USD6.2b, CMP INR2431, TP INR2576, 6% Upside, Neutral)Weak operating performance: Net sales declined 1% YoY to ~INR35.5b (5% miss). Gross margin shrunk 270bp YoY, but improved 170bp QoQ to 53.3%. EBITDA increased 10% YoY (4% miss), as margin expanded 190bp YoY to 18.7%. PAT declined 12% YoY to INR2.8b (18% miss). Despite Doxil and Vytorin launch, US sales remained under pressure at USD220m (v/s USD231m in ...
MOSL: DR REDDY’S LABS (Neutral)-German regulator issues observation...
​Dr Reddy’s Labs: German regulator issues observations at Duvvada facility; No supplies to EU from this facility; hence, no revenue impact(DRRD IN, Mkt Cap USD7.8b, CMP INR2159, TP INR2400, 11% Upside, Neutral)The German regulator conducted an audit on DRRD’s Duvvada-based Oncology injectable formulations facility. The regulator has issued six major observations post inspection of this facility. DRRD will be submitting a corrective action plan (CAPA) to the authorities, and the regulator h...
MOSL: DR REDDY’S LABS (Neutral)-Suboxone litigation in favor of DRRD...
DR REDDY’S LABS: Suboxone litigation in favor of DRRD; US FDA approval key(DRRD IN, Mkt Cap USD7.8b, CMP INR2217, TP INR2500, 13% Upside, Neutral)The District Court of Delaware (US) has ruled in favor of Dr. Reddy’s (DRRD) in the Suboxone litigation. The court found the patents ‘150, ‘514, ‘497 valid and non-infringing. According to IMS, secondary sales for Suboxone films stood at USD1.7b (primary: USD850m) in CY16. In August 2016, DRRD had acquired eight ANDAs, including gSuboxone, fr...
MOSL: DR REDDY’S LABS (Neutral)-Weak quarter-margin recovery is key
​Dr Reddy’s Labs: Weak quarter; margin recovery is key(DRRDIN, Mkt Cap USD7.0b, CMP INR2622, TP INR2500, 5% Downside, Neutral)Weak operating performance: Net sales grew 2.5% YoY to ~INR33.2b (9% miss). Gross margin shrunk ~450bp YoY, primarily due to four factors: 1) double-digit price erosion in the US business (due to new competition and channel consolidation). 2) Impact of GST implementation. 3) Manufacturing overhead deleverage. 4) INR appreciation against USD. PAT declined >50% YoY to I...
MOSL: DR REDDY’ S LABS (Neutral)-Weak quarter-US FDA resolution is k...
Dr Reddy’ s Labs: Weak quarter; US FDA resolution is key(DRRD IN, Mkt Cap USD6.7b, CMP INR2585, TP INR2600, 0.5% Upside, Neutral)Operating performance in-line: Net sales fell 5% YoY to ~INR35.5b (est. of ~INR37.5). EBITDA margin shrunk ~550bp YoY (-650bp QoQ) to 16.4%, primarily led by lower gross margin of 51% due to pricing pressure in the US and certain one-off charges. R&D expense for 4Q stood at 12.9% v/s 13.9% for the full year. 4QFY17 PAT was INR3.1b v/s our estimate of INR4.6b.US sales...
MOSL: DR REDDY’ S LABS (Neutral)-Bachupalli 483 observations–no da...
​Dr Reddy’ s Labs: Bachupalli 483 observations – no data integrity issue, but approvals may get delayed(DRRD IN, Mkt Cap USD6.8b, CMP INR2602, TP INR2625, 1% Upside, Neutral)​The USFDA inspected Dr. Reddy’s (DRRD) Bachupalli plant in April 2017, issuing 11 observations. The observation letter reveals no data integrity issues, with most observations being related to lab control, QC, assurance of back-up data, etc. Notably, there were two repeat observations.Revamp in quality control & c...
MOSL: DR REDDY’S LABS (neutral)-Duvvada 483 observations out-data in...
​Dr Reddy’s Labs: Duvvada 483 observations out; data integrity issues persist(DRRD IN, Mkt Cap USD6.6b, INR2623, TP INR2875, 10% Downside, Neutral)​Dr Reddy’s Labs (DDRD) has been issued 483 observations (4–5 are repeated) by the US FDA for its Duvvada plant. The FDA investigation has also revealed data integrity issues (e.g., Observation 3, 4). Given that the FDA has maintained a zero tolerance policy toward oncology injectable plants, we believe that the facility may remain under the...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.