Key Takeaways
- Steady quarter, execution-led: Consolidated revenue grew 9% YoY with US and Europe generics driving the beat, while India showed early signs of a planned turnaround.
- US growth story intact despite noise: Base business volume expansion and Mayne integration more than offset price erosion; management flagged 25–30 launches on track for the year.
- Biosimilars are the long game: The Bachupally facility received a UK GMP certificate but also nine US FDA observations; management called them addressable and pointed to a FY27 onwards ramp-up for the pipeline.
- Margins held the line: Gross margin dipped only ~40 bps YoY despite cost inflation, while SG&A rose on brand and digital investments; the full-year SG&A guide is 28–29% of sales.
- What to watch next quarter: Resolution of the US FDA observations, the pace of India’s exit toward double-digit growth, and any update on the Mayne portfolio’s customer discussions.
US Generics: Volume Offsets Price Erosion
- Growth engine: North America grew 9% YoY, driven by market share expansion in existing key products and the full integration of the Mayne portfolio.
- Price erosion is stable, not broad: Erosion affects only products entering a bid or RFP in a given quarter; management described this year’s erosion as more moderate than in other years and fluctuating between high single digits and low double digits.
- Volume and portfolio doing the work: Most of the sequential revenue growth came from volume growth and the Mayne portfolio, not from one-off pricing events.
- Shortage opportunities persist: The US team continues to capture short-term contracts and shortage situations by prioritizing continuity, service and sustainability of supply.
- Launch cadence confirmed: 25 to 30 launches remain on track for this year, with an equal number of material products already identified for FY25, FY26 and FY27.
- Revlimid contribution undisclosed: Management declined to discuss quantities or confirm whether Revlimid sales changed materially quarter-on-quarter, reiterating only that growth came from the base business and Mayne.
Israeli: "I believe that those observations are addressable. We are going to address all of them in the beginning of November. Some of them will require us to create a CAPA, which means we need to produce certain product for a certain period of time in order to show certain consistency of data, which will take us to January. But overall, I believe that this is addressable."
India: A Turnaround Under Construction
- Modest headline, better underneath: India grew 3% YoY; excluding the loss of revenues from NLEM-related price reductions, growth was in the mid-single digits.
- Two deliberate choices: Management trimmed the base portfolio by divesting brands and is now focused on profitable growth and sales and marketing execution, which is driving gradual improvement.
- Chronic therapies are the wedge: Chronic products now represent 35% of the India business and will grow as more chronic launches come through, a mix shift that should lift both growth and margins over time.
- Innovation pipeline converting: Products from in-licensing deals signed roughly a year ago are now launching; the typical cycle from deal signing to product approval is 12 to 18 months, longer when clinical trials are required.
- Margin advantage: India is a branded generics market and carries a better margin profile than the unbranded US and Europe businesses, a structural advantage management intends to protect.
- Sales force productivity over expansion: No immediate need to increase the sales force; the focus is on improving productivity and coverage, with additions only if required.
Israeli: "I believe that in the end of the year, we should see double-digit growth and continue in the quarters after."
Biosimilars: Building the FY27 Ramp
- Regulatory milestone, with work to do: The Bachupally biologics facility received a GMP certificate from the UK MHRA, but a US FDA pre-approval inspection concluded with nine observations. Management expects to address all observations by November, with some CAPA work extending into January.
- Pipeline depth: Five Phase-III biosimilars are slated for global launch including the US in the next two years or so, with the main revenue ramp-up expected from FY27 onwards.
- Rituximab filing progressing: The biosimilar Rituximab was submitted in April, a pre-approval inspection has been received, and the answer is due by November; launch in the US and Europe is expected at the beginning of FY25.
- Emerging markets are the current beachhead: Most biosimilar activity today is in India, Russia and other emerging markets with products like Rituximab, and that activity is ramping up.
- Pegfilgrastim is a royalty play only: The product is not Dr. Reddy’s own; it was part of an arrangement with Merck Serono and Fresenius, and the company receives only a royalty, which management described as not a big amount.
- Commercial build-out ahead: For products launching from FY27 onwards, the company will need to build a dedicated sales force, a cost that will phase in closer to launch.
Israeli: "The main ramp-up in biosimilars for us will be probably from FY27 onwards."
Europe and Emerging Markets: Steady Contributors
- Europe delivered 12% YoY growth: Driven by new product launches and volume improvement in the base business, more than offsetting price erosion; injectables and tender wins were the primary growth drivers.
- More markets, more tenders: Growth is coming from broader market participation and an increasing number of tender wins, not just a few large contracts.
- Emerging markets dipped marginally: A 1% YoY decline was attributed to seasonality and unfavorable forex; the full-year outlook remains on track.
- Russia grew in constant currency: Up 4% YoY and 9% sequentially in constant currency; like India, Russia is a branded generics market with a healthy margin profile.
- China approvals accelerating: Six approvals have now been secured, with the pace picking up since April; most products are among the first wave and normally among the first three to market, and the portfolio should start contributing meaningfully from next fiscal.
Margins, Investment and Capital Allocation
- Gross margin held broadly flat sequentially: Consolidated gross margin decreased ~40 bps YoY; Global Generics stood at 63.6% and PSAI at 17.8%.
- SG&A rose on deliberate investment: Spend increased 13% YoY and 6% QoQ, driven by investments behind brands, digitalization in the front end, R&D and manufacturing facilities; the full-year guide is 28–29% of sales.
- R&D spend to grow moderately: Driven by ongoing clinical trials on differentiated assets and developmental efforts for small molecules and the biosimilars pipeline; as a percentage of sales, R&D should stay in the current range or move slightly higher.
- Tax rate benefit structural: The lower effective tax rate versus the prior year is mainly due to the adoption of corporate tax rates under Section 115BAA; the normalized ETR is expected in the 24–25% range for the full year.
- Working capital improved: Operating working capital reduced by Rs. 598 crores, mainly due to a decrease in receivables, which management described as a normal function of credit period and order cycles.
- M&A appetite is disciplined: The company is looking for deals of all sizes but is not in a rush; the focus is on complementary activities for the organic strategy, not transformative deals.
Agarwal: "I would say 2x EBITDA is what we will be willing to go for. Beyond that, we would not like to take a financial risk."
Guidance & Commitments
| Commitment | Specifics | Timeline |
|---|---|---|
| US FDA observations (biologics) | Address all observations; CAPA work to show data consistency | Observations by Nov; CAPA through Jan |
| US launches | 25–30 launches on track | FY24 |
| US launches (forward pipeline) | 25–30 material products identified | FY25, FY26, FY27 |
| Biosimilar Rituximab (US/Europe) | Launch expected | Beginning of FY25 |
| Biosimilars main ramp-up | Five Phase-III assets launching globally including US | FY27 onwards |
| India exit growth rate | Double-digit growth | Q4 FY24 |
| India growth trajectory | Double-digit growth sustained | Quarters after FY24 |
| China meaningful contribution | Portfolio starts contributing meaningfully | Next fiscal (FY25) |
| Normalized ETR | 24% to 25% | Full year FY24 |
| SG&A as % of sales | 28% to 29% | Full year FY24 |
| R&D as % of sales | In current range or slightly higher | Ongoing |
| Government grants | Higher than last year; sustainable | Full year and next several quarters |
| M&A leverage ceiling | Willing to go to 2x EBITDA; no further | Ongoing |
Key Metrics
| Metric | Q2 FY24 |
|---|---|
| Consolidated revenue | ₹6,880 cr (US\$828 mn), +9% YoY and +2% QoQ |
| EBITDA | ₹2,181 cr (US\$263 mn), +13% YoY |
| EBITDA margin | 31.7% |
| Profit before tax | ₹1,913 cr (US\$230 mn), +19% YoY and +4% QoQ |
| Profit after tax | ₹1,480 cr (US\$178 mn) |
| Reported EPS | ₹88.8 |
| Gross profit margin | 58.7%, down ~40 bps YoY, broadly flat QoQ |
| SG&A spend | ₹1,880 cr (US\$226 mn), +13% YoY and +6% QoQ; 27.3% of sales |
| R&D spend | ₹545 cr (US\$66 mn), 7.9% of sales |
| Effective tax rate | 22.6% for the quarter; full-year normal ETR expected at 24–25% |
| Free cash flow (before acquisition payouts) | ₹1,447 cr (US\$174 mn) |
| Net surplus cash | ₹5,906 cr (US\$711 mn) as of Sep 30, 2023 |
| Annualized RoCE | 39% |
| North America Generics revenue | US\$384 mn, +9% YoY, broadly flat QoQ |
| Europe revenue | €59 mn, +12% YoY and +4% QoQ |
| Emerging Markets revenue | ₹1,216 cr, −1% YoY and +5% QoQ |
| India revenue | ₹1,186 cr, +3% YoY and +3% QoQ; mid-single-digit growth excluding NLEM and divested brands |
| PSAI revenue | US\$85 mn, +5% YoY and +4% QoQ |
| Global Generics gross margin | 63.6% |
| PSAI gross margin | 17.8% (clarified as 18% during Q&A) |
| US price erosion trend | High single-digit to low double-digit range, moderating and stable |
| New product launches in the quarter | 4 in North America, 20 in Europe, 32 in Emerging Markets |
| Global generic filings in Q2 | 6, including 2 ANDAs and 1 NDA in the US |
| Full-year US launch target | 25 to 30 launches on track |
| Material products identified for FY25–FY27 | 25 to 30 products, each with at least single-digit US\$ mn sales potential |
| India chronic therapy contribution | ~35% of India business |
| India sales force | A little more than 6,000 people |
| India in-licensing deals completed | Around 10 deals, each targeting at least ₹100 cr peak sales |
| Biosimilar Rituximab US/EU timeline | Submitted April 2023; launch expected beginning of FY25 |
| China approvals | 6 cumulative approvals; filing more than 15 products per year |
| US FDA biologics facility inspection | Pre-approval inspection concluded with 9 observations; CAPA expected by January |