Alkem Laboratories Ltd

Financial Performance

• International sales: INR 1,222 crore; YoY +16%; EBITDA margin 20.5%; growth +3.7%.
• R&D expense: 4% of total revenue.
• Profit before tax: roughly flat; PBT growth ~1.8%.
• Net profit degrew 21.7% YoY due to taxation.

Operating Update

• IQVIA: India growth 13.2% YoY; market 12.2%; 100 bps outperformance.
• Acute growth 12.3% vs IPM 10.1%; Chronic 17.9% vs 15.4%.
• 7 key therapies outperformed IPM.
• US: 5 ANDA approvals; 1 tentative approval.
• Daman facility received OAI status; approved product supplies continue to US.
• Occlutech acquisition closed mid-July; Q1 not materially impacted.
• U.S. CDMO opex ~INR60 crore per quarter; breakeven in next 4–5 quarters.
• EU: Denosumab biosimilar plan via Theramex; not a rapid ramp.
• Xgeva biosimilar: could be launch around 3 months away.
• India biosimilars: 7 products launched; ~INR150 crore annual sales; margins improved via backward integration.
• Daman accounts for ~45% of U.S. revenue.

Projects and Capex

• Occlutech target: INR400 crore sales with breakeven EBITDA; integration delays.
• Integration with India ops starts next quarter; margins to improve over 3–4 years.

Guidance and Outlook

• Consolidated tax rate guidance: 30%–32% due to losses at Enzene/U.S. entities.
• US CDMO breakeven run-rate: USD 25–30 million annual revenue.
• Occlutech: target INR400 crore sales with breakeven EBITDA; progress to meet 3–4 year plan.
• India growth for the year: around 12%; potential 100 bps uplift possible.
• India mix: price growth ~6%; new launches ~3%; volume ~2% for the quarter.
• US growth outlook: high single-digit to mid single-digit; currency benefits expected.

Q&A Highlights

• Denosumab EU biosimilar: plan ~3 months away; Theramex partnership; not direct.
• Xgeva EU biosimilar: launch ~3 months away.
• India biosimilars: 7 products launched; INR150 crore annual sales; margins improved.
• Occlutech: 8.5 months since closing; INR400 crore sales goal; breakeven EBITDA; integration starts next quarter.
• US CDMO: quarterly opex ~INR60 crore; breakeven in 4–5 quarters; revenue run-rate target USD25–30 million.
• Daman contributes ~45% of US revenue; Daman OAI not expected to impact this year.

Risks and Watchpoints

• CDMO timing is lumpy; breakeven not expected within next 12 months.
• Daman OAI status may affect pace of US/CDMO ramp; short-term resilience seen.
• Trade Generics competition remains intense; late single-digit India growth possible.

Purpose

• Amalgamation scheme between Adroit Biomed and Alkem Laboratories under Companies Act

Key Resolutions

• Approval of the Scheme of amalgamation between Adroit Biomed and Alkem Laboratories

Voting Outcome

• Promoter group: 100% in favour of the scheme
• Public: 99.9987% in favour, 0.0013% against
• Overall: 83.62% of shares polled; 99.9999% in favour

Shareholder/Creditor Impact

• No exchange ratio or capital-structure details disclosed in this filing

Next Steps

• Results to be disseminated to stock exchanges and uploaded on the company's and CDS websites

Meeting Details

• Event: Q1FY27 Earnings Conference Call; format is an audio recording.
• Availability: Audio recording of the call is available on the company's investor site.
• Purpose: Earnings results discussion for Q1FY27.
• Key company participant: President – Legal, Company Secretary & Compliance Officer.

Alkem Laboratories Ltd – Trading Window opening; closure for the quarter ended 30 June 2026 started 29 June 2026 until expiry of 48 hours after the date on which the Financial Results for the quarter ended 30 June 2026 are communicated to the Stock Exchanges (communication on 17 August 2026).

Financials

• Total revenue ₹37,402 Mn, up 10.9% YoY.
• EBITDA ₹7,661 Mn, margin 20.5%, up 3.7% YoY.
• PAT after NCI ₹5,200 Mn, down 21.7% YoY.
• R&D spend ₹1,502 Mn, 4.0% of revenue.

Geographic & Segment Performance

• Domestic ₹24,978 Mn, 67.1% of total; up 10.3% YoY.
• US ₹7,439 Mn, up 6.5% YoY; 20.0% of total.
• Non-US ₹4,785 Mn, up 34.5% YoY; 12.9% of total.

Regulatory & Regulatory Status

• Daman facility: OAI in Aug 2026.
• Baddi facility: EIR received Jun 2024.
• Taloja Biotech: No observation.
• Ankleshwar API: EIR received Jul 2023.
• California API: EIR received Oct 2025.

Capital & Liquidity

• Net cash ₹57.64 Bn as of 30-Jun-2026.
• ANDA filings 192; approvals 170 (incl. 18 tentative).
• NDAs approvals 2.

Strategy & Outlook

• Investing in R&D, MedTech, Biotech for next growth phase.
• Focus on strengthening core and expanding newer opportunities.

New block at Baddi facility; 75 crore investment

• Board approves setting up a new block at the existing Baddi, Himachal Pradesh facility.
• Investment approval up to INR 75 crores.

Consolidated results

• Consolidated revenue from operations: ₹37,401.5 Mn; YoY growth 10.9%.
• Total income: ₹38,929.0 Mn; QoQ not specified.
• EBITDA ₹7,661 Mn; EBITDA margin 20.5%.
• PAT attributable to owners: ₹5,199.6 Mn; PAT margin 13.9%.
• US revenue ₹7,439 Mn; 20% of total.
• Domestic revenue ₹24,978 Mn; 67.1% of total.
• R&D spend ₹1,502 Mn; 4.0% of revenue.
• Net cash ₹57.64 Bn as of 30 June 2026.
• ANDA approvals: 5 in US (incl. 1 tentative); 192 ANDAs filed; 170 approvals (incl. 18 tentative).
• Consolidated exceptional item: net charge ₹1,349.7 Mn.

Geographic mix

• US revenue grew 6.5% YoY to ₹7,439 Mn; US share 20%.
• Non-US revenue grew 34.5% YoY to ₹4,785 Mn; share 12.9%.
• Domestic revenue grew 10.3% YoY to ₹24,978 Mn; share 67.1%.

R&D & liquidity

• R&D spend ₹1,502 Mn; 4.0% of revenue.
• Net cash position ₹57.64 Bn.

Outlook & risks

• FY27 started steadily; focus on India and international growth.
• Investing in R&D, MedTech and Biotech for next growth phase.
• Regulatory risk includes Daman facility OAI observed Aug 2026.

FDA inspection update

• Facility located at Amaliya, Daman; inspection conducted Apr 20–May 1, 2026.
• Form 483 issued with seven observations.
• FDA status updated to Official Action Indicated (OAI).
• Company will continue manufacturing and supplying approved products to the U.S. market.
• Company will work with regulator to achieve full compliance.

AGM notice and AR access

• 52nd AGM to be held on 27 August 2026 at 11:00 AM (IST) via VC/OAVM.
• Web-link to access the FY2025-26 Annual Report will be sent to shareholders without registered emails.
• Annual Report for FY2025-26 is available on the company website at investors/annual-reports.
• Cut-off date for email-address registration to receive AR materials is 10 July 2026.
• Disclosures issued under SEBI LODR 36(1)(b) for email-based AR delivery.