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CIPLA Healthcare 26 Jul 2024

Cipla Ltd — Q1 FY25

Cipla delivered a strong Q1 FY25 with revenue of INR 6,694 crore (+7% YoY) and EBITDA margin of 25.6% (+154 bps YoY), driven by a favorable product mix and calibrated pricing.

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Revenue ₹6,694 Cr +7%
EBITDA +14%
EBITDA Margin 25.6% +154bps
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Read Time 1 min read

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Cipla delivered a strong Q1 FY25 with revenue of INR 6,694 crore (+7% YoY) and EBITDA margin of 25.6% (+154 bps YoY), driven by a favorable product mix and calibrated pricing. North America hit an all-time high of $250 million (+13% YoY), supported by Lanreotide generic launch and Albuterol market share gains to 17%. India branded prescription grew 10% YoY, while trade generic transition was completed, impacting near-term growth. PAT stood at INR 1,178 crore (17.6% of sales). Management guided EBITDA margin of 24.5%-25.5% for FY25 and expects U.S. sustainable run rate of $235-240 million. Key risks include Goa facility FDA classification (six 483 observations) and potential price erosion in Albuterol with new entrants.

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Goa facility FDA classification pending

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Quarter Snapshot

North America Revenue $250M
+13% YoY

All-time high quarterly revenue driven by Lanreotide generic launch and Albuterol market share gains.

Albuterol Market Share 17%
+4pp QoQ

Recaptured market share in Albuterol, gaining 4% in the quarter.

India Chronic Mix 61.5%
+106bps YoY

Chronic share improved to 61.5% as per IQVIA MAT June 2024, indicating better therapy mix.

Lanreotide Market Share 20%
flat

Maintained 20% market share for Lanreotide 505(b)(2) during the quarter.

What Changed vs Last Quarter

Comparing Q1 FY25 vs Q4 FY24
3 new guidance3 dropped4 new risk4 risk resolved
NEW
U.S. sustainable quarterly run rate of $235-240 million

Expect U.S. business to settle at $235-240 million per quarter going forward, excluding one-time benefits.

NEW
Two peptide launches expected in H2 FY25

Two additional peptide products are expected to launch in Q3 and Q4 of FY25, with two more following in subsequent years.

NEW
Advair filing by end of 2024, potential launch in H1 CY2025

ANDA filing for Advair expected by December 2024 or January 2025, with potential launch in first half of calendar 2025.

UPDATED
EBITDA margin guidance of 24.5%-25.5% for FY25

Management reiterated EBITDA margin range of 24.5%-25.5% for the full year, despite strong Q1 performance.

DROPPED
Capex of INR 1,500 crore in FY25

Capital investments planned to enhance manufacturing capability and sustainability.

DROPPED
North America revenue growth aspiration for FY25

Aim to grow top line YoY, backed by commercial execution of existing portfolio and new launches.

DROPPED
Launch of 4 peptide assets in FY25

Targeting to launch four peptide assets during the fiscal year.

NEW RISK
Goa facility FDA classification pending

Goa facility received six 483 observations after U.S. FDA reinspection; official classification awaited, which could impact product approvals.

NEW RISK
Potential price erosion from new Albuterol entrants

New competitors entering the Albuterol inhalation market could lead to price erosion and market share loss, though management notes market expansion.

NEW RISK
Lanreotide supply constraints limiting ramp-up

Supply from partner is constrained, leading to gradual ramp-up for Lanreotide generic; capacity limitations may cap near-term revenue.

NEW RISK
Trade generic transition disruption

Transition to new distribution model caused temporary softness in trade generic business; recovery expected but execution risk remains.

RISK GONE
USFDA observations at Patalganga and Kurkumbh facilities

Patalganga received six 483 observations and Kurkumbh one; official classification awaited, potentially delaying product approvals.

RISK GONE
Trade generics channel restructuring disruption

Transition to direct stockist model may cause temporary hiccups in Q1 FY25, impacting trade generics growth.

RISK GONE
Timing uncertainty for Goa plant reinspection and Abraxane launch

Goa plant reinspection expected around July-August 2024; Abraxane launch depends on inspection outcome and subsequent 90-day process.

RISK GONE
Potential pricing pressure in Lanreotide market

As a two-player market, pricing may vary depending on competitor actions, though management aims to grow total value.

🤫 Topics management stopped discussing

Generic Symbicort filing in Q3 FY24

Mentioned in Q1 FY24, Q2 FY24, Q3 FY24

Filed generic Symbicort and one other inhalation asset; second site transfer to be added before approval.

Albuterol recall and market share loss

Mentioned in Q1 FY24, Q2 FY24

Albuterol share is dependent on which variant the market buys; recovery to prior highs is not fully in Cipla's control.

Goa facility re-inspection uncertainty

Mentioned in Q1 FY24, Q3 FY24

Goa facility due for re-inspection; delay or adverse outcome could further delay Abraxane launch.

Potential pricing pressure in Lanreotide market

Mentioned in Q1 FY24, Q4 FY24

As a two-player market, pricing may vary depending on competitor actions, though management aims to grow total value.

Timing uncertainty for Goa plant reinspection and Abraxane launch

Mentioned in Q3 FY24, Q4 FY24

Goa plant reinspection expected around July-August 2024; Abraxane launch depends on inspection outcome and subsequent 90-day process.

Fast read

Guidance and risk preview

Top guidance EBITDA margin guidance of 24.5%-25.5% for FY25

Management reiterated EBITDA margin range of 24.5%-25.5% for the full year, despite strong Q1 performance.

Top risk Goa facility FDA classification pending

Goa facility received six 483 observations after U.S.

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