Reported Earnings • Jul 14
Full year 2026 earnings: EPS in line with expectations, revenues disappoint Full year 2026 results: EPS: ₹34.33 (up from ₹29.68 in FY 2025). Revenue: ₹73.4b (up 10% from FY 2025). Net income: ₹6.75b (up 16% from FY 2025). Profit margin: 9.2% (up from 8.7% in FY 2025). The increase in margin was driven by higher revenue. Post-clinical trial products Pre-registration: 157 Approved (during full year): 22 Launched (during full year): 27 Revenue missed analyst estimates by 1.1%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 11% per year whereas the company’s share price has increased by 8% per year. Declared Dividend • Jul 13
Dividend increased to ₹12.00 Dividend of ₹12.00 is 9.1% higher than last year. Ex-date: 29th July 2026 Payment date: 4th September 2026 Dividend yield will be 1.4%, which is higher than the industry average of 0.8%. Sustainability & Growth Dividend is covered by both earnings (35% earnings payout ratio) and cash flows (82% cash payout ratio). The dividend has increased by an average of 12% per year over the past 10 years. However, payments have been volatile during that time. EPS is expected to grow by 61% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Announcement • Jul 11
Alembic Pharmaceuticals Limited announces Annual dividend, payable on September 04, 2026 Alembic Pharmaceuticals Limited announced Annual dividend of INR 12.0000 per share payable on September 04, 2026, ex-date on July 29, 2026 and record date on July 29, 2026. Announcement • Jun 19
Alembic Pharmaceuticals Limited Receives USFDA Tentative Approval For Binimetinib Tablets, 45 Mg Alembic Pharmaceuticals Limited has received US Food & Drug Administration (USFDA) Tentative Approval for Binimetinib Tablets, 45 mg. Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Binimetinib Tablets, 45 mg. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Refer label for a detailed indication. Based on FDA’s Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US. Binimetinib Tablets have an estimated market size of USD 259 million for twelve months ending March 2026 according to IQVIA. Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA. Announcement • Jun 13
Alembic Pharmaceuticals Limited Receives USFDA Tentative Approval for Larotrectinib Capsules, 25 mg and 100 mg Alembic Pharmaceuticals Limited has received US Food & Drug Administration (USFDA) Tentative Approval for Larotrectinib Capsules, 25 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer). Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: a) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, b) are metastatic or where surgical resection is likely to result in severe morbidity, and c) have no satisfactory alternative treatments or that have progressed following treatment. Refer label for a detailed indication. Based on the most recent update to the FDA’s online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg), containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of USD 91 million for twelve months ending March 2026 according to IQVIA. Alembic has a cumulative total of 241 ANDA approvals (221 final approvals and 20 tentative approvals) from USFDA. Announcement • Jun 10
Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 05, 2026 Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 05, 2026, at 16:00 Indian Standard Time. Reported Earnings • May 18
Full year 2026 earnings: EPS in line with expectations, revenues disappoint Full year 2026 results: EPS: ₹34.33 (up from ₹29.68 in FY 2025). Revenue: ₹74.0b (up 11% from FY 2025). Net income: ₹6.75b (up 16% from FY 2025). Profit margin: 9.1% (up from 8.7% in FY 2025). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 1.1%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 9.7% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 11% per year whereas the company’s share price has increased by 13% per year. Announcement • Apr 29
Alembic Pharmaceuticals Limited to Report Q4, 2026 Results on May 15, 2026 Alembic Pharmaceuticals Limited announced that they will report Q4, 2026 results at 12:08 PM, Indian Standard Time on May 15, 2026 Reported Earnings • Feb 06
Third quarter 2026 earnings: EPS misses analyst expectations Third quarter 2026 results: EPS: ₹6.76 (down from ₹7.01 in 3Q 2025). Revenue: ₹18.9b (up 12% from 3Q 2025). Net income: ₹1.33b (down 3.9% from 3Q 2025). Profit margin: 7.0% (down from 8.2% in 3Q 2025). The decrease in margin was driven by higher expenses. Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 26%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 18% per year whereas the company’s share price has increased by 15% per year. Announcement • Jan 20
Alembic Pharmaceuticals Limited to Report Q3, 2026 Results on Feb 05, 2026 Alembic Pharmaceuticals Limited announced that they will report Q3, 2026 results on Feb 05, 2026 Announcement • Jan 12
Alembic Pharmaceuticals Limited Receives USFDA Tentative Approval for Bosutinib Tablets, 400 Mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. (PF Prism C.V.). Bosutinib is a kinase inhibitor indicated for the treatment of i) adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy, and ii) adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. Alembic had previously received final approval for its ANDA BosutinibTablets, 100 mg and 500mg. Refer label for a detailed indication. Bosutinib Tablets., have an estimated market size of USD 251 million for twelve months ending September 2025 according to IQVIA. Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA. Reported Earnings • Nov 05
Second quarter 2026 earnings: EPS and revenues exceed analyst expectations Second quarter 2026 results: EPS: ₹9.40 (up from ₹7.79 in 2Q 2025). Revenue: ₹19.2b (up 16% from 2Q 2025). Net income: ₹1.85b (up 20% from 2Q 2025). Profit margin: 9.6% (in line with 2Q 2025). Revenue exceeded analyst estimates by 6.5%. Earnings per share (EPS) also surpassed analyst estimates by 8.1%. Revenue is forecast to grow 9.6% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has only increased by 15% per year, which means it is significantly lagging earnings growth. Announcement • Oct 23
Alembic Pharmaceuticals Limited to Report Q2, 2026 Results on Nov 04, 2025 Alembic Pharmaceuticals Limited announced that they will report Q2, 2026 results on Nov 04, 2025 Announcement • Oct 20
Alembic Pharmaceuticals Limited Receives USFDA Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL ( Single-Dose and Multiple-Dose Vials Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL Single-Dose Vials, 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kenalog-40 Injectable Suspension, of Bristol-Myers Squibb Company. Triamcinolone Acetonide Injectable Suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, has an estimated market size of USD 96 million for twelve months ending June 2025 according to IQVIA. Announcement • Aug 19
Alembic Pharmaceuticals Limited Announces USFDA Final Approval for Macitentan Tablets, 10 Mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US Inc. (Actelion). Mac Pen Pen Penial Tablets, 10 mg, have an estimated market size of USD 1,180 million for twelve months ending June 2025 according to IQVIA. Alembic has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA. Reported Earnings • Aug 06
First quarter 2026 earnings: EPS and revenues miss analyst expectations First quarter 2026 results: EPS: ₹7.85 (up from ₹6.84 in 1Q 2025). Revenue: ₹17.2b (up 10.0% from 1Q 2025). Net income: ₹1.54b (up 15% from 1Q 2025). Profit margin: 9.0% (up from 8.6% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 1.7%. Earnings per share (EPS) also missed analyst estimates by 1.9%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has only increased by 13% per year, which means it is significantly lagging earnings growth. Upcoming Dividend • Jul 22
Upcoming dividend of ₹11.00 per share Eligible shareholders must have bought the stock before 29 July 2025. Payment date: 04 September 2025. Payout ratio is a comfortable 37% but the company is not cash flow positive. Trailing yield: 1.1%. Lower than top quartile of Indian dividend payers (1.2%). Higher than average of industry peers (0.8%). Announcement • Jul 21
Alembic Pharmaceuticals Limited to Report Q1, 2026 Results on Aug 05, 2025 Alembic Pharmaceuticals Limited announced that they will report Q1, 2026 results on Aug 05, 2025 Reported Earnings • Jun 18
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: EPS: ₹29.68 (down from ₹31.33 in FY 2024). Revenue: ₹66.7b (up 7.1% from FY 2024). Net income: ₹5.83b (down 5.3% from FY 2024). Profit margin: 8.7% (down from 9.9% in FY 2024). The decrease in margin was driven by higher expenses. Post-clinical trial products Pre-registration: 72 Approved (during full year): 56 Launched (during full year): 51 Revenue exceeded analyst estimates by 1.8%. Earnings per share (EPS) also surpassed analyst estimates by 3.8%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has only increased by 10% per year, which means it is significantly lagging earnings growth. Announcement • Jun 12
Alembic Pharmaceuticals Limited announces Annual dividend, payable on September 04, 2025 Alembic Pharmaceuticals Limited announced Annual dividend of INR 11.0000 per share payable on September 04, 2025, ex-date on July 29, 2025 and record date on July 29, 2025. Announcement • May 22
Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 05, 2025 Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 05, 2025, at 15:00 Indian Standard Time. Valuation Update With 7 Day Price Move • May 19
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₹1,028, the stock trades at a forward P/E ratio of 28x. Average forward P/E is 30x in the Pharmaceuticals industry in India. Total returns to shareholders of 40% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at ₹881 per share. Reported Earnings • May 10
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: EPS: ₹29.68 (down from ₹31.33 in FY 2024). Revenue: ₹67.1b (up 7.8% from FY 2024). Net income: ₹5.83b (down 5.3% from FY 2024). Profit margin: 8.7% (down from 9.9% in FY 2024). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 1.8%. Earnings per share (EPS) also surpassed analyst estimates by 3.8%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has only increased by 7% per year, which means it is significantly lagging earnings growth. Announcement • Apr 18
Alembic Pharmaceuticals Limited to Report Q4, 2025 Results on May 06, 2025 Alembic Pharmaceuticals Limited announced that they will report Q4, 2025 results on May 06, 2025 Announcement • Apr 17
Alembic Pharmaceuticals Limited Receives Final Approval from the US Food & Drug Administration for Its Abbreviated New Drug Application Carbamazepine Tablets USP, 200 Mg Alembic Pharmaceuticals Limited announced that it has received Final Approval from the US Food & Drug Administration for its Abbreviated New Drug Application Carbamazepine Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine tablets USP, 200 mg are indicated for use as an anticonvulsant drug. It is also indicated in the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication. Valuation Update With 7 Day Price Move • Mar 24
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₹963, the stock trades at a forward P/E ratio of 26x. Average forward P/E is 32x in the Pharmaceuticals industry in India. Total returns to shareholders of 32% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at ₹521 per share. Recent Insider Transactions • Mar 20
Executive Chairman & CEO recently bought ₹4.8m worth of stock On the 17th of March, Chirayu Amin bought around 6k shares on-market at roughly ₹826 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth ₹39m. Chirayu has been a buyer over the last 12 months, purchasing a net total of ₹83m worth in shares. Recent Insider Transactions • Feb 25
Executive Chairman & CEO recently bought ₹779k worth of stock On the 20th of February, Chirayu Amin bought around 959 shares on-market at roughly ₹812 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth ₹21m. Chirayu has been a buyer over the last 12 months, purchasing a net total of ₹30m worth in shares. Recent Insider Transactions • Feb 18
Executive Chairman & CEO recently bought ₹21m worth of stock On the 13th of February, Chirayu Amin bought around 25k shares on-market at roughly ₹842 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Chirayu's only on-market trade for the last 12 months. Price Target Changed • Feb 12
Price target decreased by 9.2% to ₹1,063 Down from ₹1,171, the current price target is an average from 12 analysts. New target price is 26% above last closing price of ₹845. Stock is down 14% over the past year. The company is forecast to post earnings per share of ₹28.80 for next year compared to ₹31.33 last year. Announcement • Feb 12
Alembic Pharmaceuticals Limited Announces Cessation of Dhananjay Wyawahare as Head-Site Operations (Derma) Alembic Pharmaceuticals Limited announced that February 11, 2025, due to change in internal reporting structures, Mr. Dhananjay Wyawahare, Head-Site Operations (Derma) shall cease to be a Senior Management Personnel. Reported Earnings • Feb 04
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: EPS: ₹7.01 (down from ₹9.18 in 3Q 2024). Revenue: ₹16.9b (up 3.8% from 3Q 2024). Net income: ₹1.38b (down 23% from 3Q 2024). Profit margin: 8.2% (down from 11% in 3Q 2024). The decrease in margin was driven by higher expenses. Revenue missed analyst estimates by 2.5%. Earnings per share (EPS) also missed analyst estimates by 12%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth. Announcement • Jan 22
Alembic Pharmaceuticals Limited to Report Q3, 2025 Results on Feb 03, 2025 Alembic Pharmaceuticals Limited announced that they will report Q3, 2025 results on Feb 03, 2025 Announcement • Dec 05
Alembic Pharmaceuticals Limited Announces USFDA Tentative Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% Alembic Pharmaceuticals Limited (Alembic) announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories Inc. (Alcon) NDA - 206276. Olopatadine Hydro chloride Ophthalmic Solution UP, 0.7% ("OTC") is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication. Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA. Reported Earnings • Nov 08
Second quarter 2025 earnings: EPS and revenues miss analyst expectations Second quarter 2025 results: EPS: ₹7.79 (up from ₹6.95 in 2Q 2024). Revenue: ₹16.6b (up 4.4% from 2Q 2024). Net income: ₹1.53b (up 12% from 2Q 2024). Profit margin: 9.2% (up from 8.6% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 3.5%. Earnings per share (EPS) also missed analyst estimates by 5.6%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has increased by 10% per year, which means it is well ahead of earnings. Announcement • Nov 07
Alembic Pharmaceuticals Limited Announces Superannuation of Vipul Gandhi, Head - Business Development - Formulations Alembic Pharmaceuticals Limited announced that Mr. Vipul Gandhi, Head - Business Development - Formulations, has superannuated from the said position. Date of cessation: 31 October 2024 after closure of business hours. Announcement • Oct 21
Alembic Pharmaceuticals Limited Receives Final Approval from the US Food & Drug Administration for its Abbreviated New Drug Application Diltiazem Hydrochloride Extended-Release Capsules Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan). Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. It is also indicated for the management of chronic stable angina. Refer label for a detailed indication. Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size of USD 28.2 million for twelve months ending June 2024 according to IQVIA. Announcement • Oct 18
Alembic Pharmaceuticals Limited to Report Q2, 2025 Results on Nov 07, 2024 Alembic Pharmaceuticals Limited announced that they will report Q2, 2025 results on Nov 07, 2024 Buy Or Sell Opportunity • Oct 15
Now 21% overvalued after recent price rise Over the last 90 days, the stock has risen 6.1% to ₹1,150. The fair value is estimated to be ₹952, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 7.0% over the last 3 years. Earnings per share has declined by 16%. Revenue is forecast to grow by 25% in 2 years. Earnings are forecast to grow by 47% in the next 2 years. Announcement • Oct 06
Alembic Pharmaceuticals Limited Announces USFDAFinal Approval for Lamotrigine Extended-Release Tablets Usp, 200 mg, 250 mg, and 300 mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg,250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK). Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Also indicated for conversion to monotherapy in patients age 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. Refer label for a detailed indication. Lamotrigine Extended- release Tablets USP, 200 u mg, 250 mg, and300 mg have an estimated market size of USD 163 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA. Announcement • Sep 16
Alembic Pharmaceuticals Limited Appoints Mr. Sudhakar Pandiyan as Head - Technical Operations Alembic Pharmaceuticals Limited informed that Mr. Sudhakar Pandiyan, is appointed as Head - Technical Operations (Sterile & Oncology), designated as Senior Management Personnel of the Company w.e.f. 16th September 2024. Mr. Sudhakar Pandiyan has done Master of Science in Microbiology from MS University, Tamil Nadu and Bachelor of Science in microbiology, University of Madras. Mr. Sudhakar Pandiyan has around 20 years of progressive experience in sterile products manufacturing and quality operations. He has been associated with Caplin Steriles Ltd., Mylan Laboratories Limited, Caplin Point Laboratories Limited, Strides Arcolab Limited and Novartis Vaccines and Diagnostics. Over the last 2.5 years, he has been associated as a consultant with various pharmaceuticals companies. Price Target Changed • Sep 11
Price target increased by 7.2% to ₹1,056 Up from ₹985, the current price target is an average from 12 analysts. New target price is 15% below last closing price of ₹1,249. Stock is up 61% over the past year. The company is forecast to post earnings per share of ₹34.88 for next year compared to ₹31.33 last year. Valuation Update With 7 Day Price Move • Sep 10
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₹1,243, the stock trades at a forward P/E ratio of 32x. Average forward P/E is 37x in the Pharmaceuticals industry in India. Total returns to shareholders of 66% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at ₹995 per share. Buy Or Sell Opportunity • Sep 09
Now 25% overvalued after recent price rise Over the last 90 days, the stock has risen 34% to ₹1,204. The fair value is estimated to be ₹964, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 7.0% over the last 3 years. Earnings per share has declined by 16%. Revenue is forecast to grow by 24% in 2 years. Earnings are forecast to grow by 45% in the next 2 years. Announcement • Aug 24
Alembic Pharmaceuticals Limited Receives Final Approval from the US Food & Drug Administration for Its Abbreviated New Drug Application Betamethasone Valerate Foam, 0.12% Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12%, of Norvium Bioscience, LLC (Norvium). Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Refer label for a detailed indication. Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA. Announcement • Aug 22
Alembic Pharmaceuticals Limited Announces Resignation of Nilesh Shah as Head Legal Alembic Pharmaceuticals Limited announced that Mr. Nilesh Shah, Head Legal, has resigned from the said position to pursue opportunities outside the Company. Reported Earnings • Aug 09
First quarter 2025 earnings: EPS and revenues miss analyst expectations First quarter 2025 results: EPS: ₹6.84 (up from ₹6.14 in 1Q 2024). Revenue: ₹15.6b (up 5.2% from 1Q 2024). Net income: ₹1.35b (up 12% from 1Q 2024). Profit margin: 8.6% (up from 8.1% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 4.9%. Earnings per share (EPS) also missed analyst estimates by 17%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has increased by 14% per year, which means it is well ahead of earnings. Announcement • Jul 25
Alembic Pharmaceuticals Limited to Report Q1, 2025 Results on Aug 08, 2024 Alembic Pharmaceuticals Limited announced that they will report Q1, 2025 results on Aug 08, 2024 Announcement • Jul 24
Alembic Pharmaceuticals Receives USFDA Final Approval for Fluphenazine Hydrochloride Tablets USP, 1 Mg, 2.5 Mg, 5 Mg, and 10 Mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolixin Tablets, 1 mg, 2.5 mg, 5mg, and 10 mg, of Apothecon Inc. (Apothecon). Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders. Refer label for a detailed indication. Alembic has a cumulative total of 210 ANDA approvals (182 final approvals and 28 tentative approvals) from USFDA. Announcement • Jul 12
Alembic Pharmaceuticals Limited Announces USFDA Tentative Approval for Selexipag for Injection, 1,800 Mc/Vial Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi® for Injection, 1, 800 mcg/vial, of Actelion Pharmaceuticals US Inc. (Actelion). Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Refer label for a detailed indication. Based on the most recent update to the FDA's online paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Selexipag for In injection, 1,800 mcg-vial, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. Alembic has a cumulative total of 208 ANDA approvals (180 final approvals and 28 tentative approvals) from USFDA. Announcement • Jul 09
Alembic Pharmaceuticals Announces Usfda Final Approval for Bromfenac Ophthalmic Solution, 0.07% Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Incorporated (Bausch). Bromfenac Ophthalmic Solution 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Refer label for a detailed indication. Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of USD 168 million for twelve months ending March 2024 according to IQVIA. Upcoming Dividend • Jul 08
Upcoming dividend of ₹11.00 per share Eligible shareholders must have bought the stock before 15 July 2024. Payment date: 21 August 2024. Payout ratio is a comfortable 35% and this is well supported by cash flows. Trailing yield: 1.1%. Within top quartile of Indian dividend payers (1.1%). Higher than average of industry peers (0.7%). Announcement • Jul 04
Alembic Pharmaceuticals Limited Receives USFDATentative Approval for Ivosidenib Tablets 250 Mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier). Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) Newly Diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy (b) Adult patients with Relapsed or refractory AML (c) Adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated. Buy Or Sell Opportunity • Jul 01
Now 21% overvalued Over the last 90 days, the stock has fallen 7.8% to ₹924. The fair value is estimated to be ₹762, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 5.9% over the last 3 years. Earnings per share has declined by 30%. For the next 3 years, revenue is forecast to grow by 11% per annum. Earnings are also forecast to grow by 18% per annum over the same time period. Reported Earnings • Jun 25
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: EPS: ₹31.33 (up from ₹17.40 in FY 2023). Revenue: ₹62.3b (up 10% from FY 2023). Net income: ₹6.16b (up 80% from FY 2023). Profit margin: 9.9% (up from 6.1% in FY 2023). The increase in margin was driven by higher revenue. Post-clinical trial products Pre-registration: 90 Approved (during full year): 15 Launched (during full year): 41 Revenue missed analyst estimates by 1.6%. Earnings per share (EPS) exceeded analyst estimates by 3.7%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 9.9% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has only fallen by 3% per year, which means it has not declined as severely as earnings. Declared Dividend • Jun 24
Dividend increased to ₹11.00 Dividend of ₹11.00 is 38% higher than last year. Ex-date: 15th July 2024 Payment date: 21st August 2024 Dividend yield will be 1.3%, which is higher than the industry average of 0.8%. Sustainability & Growth Dividend is well covered by both earnings (35% earnings payout ratio) and cash flows (45% cash payout ratio). The dividend has increased by an average of 14% per year over the past 10 years. However, payments have been volatile during that time. EPS is expected to grow by 64% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Announcement • Jun 10
Alembic Pharmaceuticals Limited, Annual General Meeting, Jul 22, 2024 Alembic Pharmaceuticals Limited, Annual General Meeting, Jul 22, 2024, at 15:00 Indian Standard Time. Announcement • Jun 08
Alembic Pharmaceuticals Limited Announces Superannuation of Chandrahas Shetty as President-Human Resources (India Branded Business) Alembic Pharmaceuticals Limited announced that Mr. Chandrahas Shetty, President-Human Resources (India Branded Business), is superannuating from the said position. Date of cessation (as applicable) & term of appointment: 7th June, 2024 after closure of business hours. Buy Or Sell Opportunity • May 29
Now 20% overvalued Over the last 90 days, the stock has fallen 7.0% to ₹946. The fair value is estimated to be ₹786, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 5.9% over the last 3 years. Earnings per share has declined by 30%. For the next 3 years, revenue is forecast to grow by 11% per annum. Earnings are also forecast to grow by 18% per annum over the same time period. Reported Earnings • May 10
Full year 2024 earnings released: EPS: ₹31.33 (vs ₹17.40 in FY 2023) Full year 2024 results: EPS: ₹31.33 (up from ₹17.40 in FY 2023). Revenue: ₹62.6b (up 11% from FY 2023). Net income: ₹6.16b (up 80% from FY 2023). Profit margin: 9.8% (up from 6.1% in FY 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has increased by 1% per year, which means it is well ahead of earnings. Announcement • Apr 20
Alembic Pharmaceuticals Limited to Report Q4, 2024 Results on May 09, 2024 Alembic Pharmaceuticals Limited announced that they will report Q4, 2024 results on May 09, 2024 Price Target Changed • Apr 12
Price target increased by 8.4% to ₹933 Up from ₹861, the current price target is an average from 13 analysts. New target price is 5.2% below last closing price of ₹984. Stock is up 87% over the past year. The company is forecast to post earnings per share of ₹30.20 for next year compared to ₹17.40 last year. Price Target Changed • Feb 07
Price target increased by 7.4% to ₹827 Up from ₹770, the current price target is an average from 15 analysts. New target price is 15% below last closing price of ₹974. Stock is up 85% over the past year. The company is forecast to post earnings per share of ₹30.53 for next year compared to ₹17.40 last year. Reported Earnings • Feb 06
Third quarter 2024 earnings: Revenues in line with analyst expectations Third quarter 2024 results: Revenue: ₹16.3b (up 8.2% from 3Q 2023). Net income: ₹1.80b (up 48% from 3Q 2023). Profit margin: 11% (up from 8.1% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Announcement • Jan 19
Alembic Pharmaceuticals Limited to Report Q3, 2024 Results on Feb 05, 2024 Alembic Pharmaceuticals Limited announced that they will report Q3, 2024 results on Feb 05, 2024 Valuation Update With 7 Day Price Move • Jan 15
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₹942, the stock trades at a forward P/E ratio of 31x. Average forward P/E is 31x in the Pharmaceuticals industry in India. Total loss to shareholders of 8.3% over the past three years. Announcement • Dec 04
Alembic Pharmaceuticals Limited Appoints Pradeep Chakravarty as Head - Global Quality Alembic Pharmaceuticals Limited announced that Mr. Pradeep Chakravarty has joined the Company w.e.f. 4th December, 2023, as Head - Global Quality (Senior Management Personnel of the Company). Brief Profile: Mr. Pradeep Chakravarty has vast experience of more than 29 years in the field of Corporate Quality Assurance, Regulatory Affairs and Pharma- covigilance. He has done M. Tech (Industrial Engineering) from Calicut University and B.E (Mechanical Engineering) from Andhra University. Prior to joining the Company, he was working with Lupin Limited for more than 11 years. He had also worked for Claris Lifesciences Limited, Nefron Dialysis Services and Core Healthcare Limited. Announcement • Nov 29
Alembic Pharmaceuticals Limited Announces Management Changes Alembic Pharmaceuticals Limited announced that Mr. Mohith Santosh Kumar has joined the Company with effect from 27th November, 2023, in the capacity of Executive Assistant to Mr. Pranav Amin, Managing Director (Senior Management Personnel of the Company) and shall also head the Launch Strategy. Mr. Mohith Santosh Kumar has experience of more than 9 years in the field of Projects & Planning. He has done B. Tech. (Genetic Engineering) from SRM University, Chennai and Masters of Business Administration (MBA) from Gnanam School of Business, Thanjavur. Prior to joining the Company, he was associated with Caplin Steriles Limited for about 4 years. He had also worked with Boffin Biotech Pvt. Ltd. He has rich experience in dealing with US based clients for commercial product launch. Announcement • Oct 17
Alembic Pharmaceuticals Limited to Report Q2, 2024 Results on Nov 07, 2023 Alembic Pharmaceuticals Limited announced that they will report Q2, 2024 results on Nov 07, 2023 Announcement • Sep 02
Alembic Pharmaceuticals Limited Announces Resignation of Jesal Shah as Head - Strategy Alembic Pharmaceuticals Limited announced that Mr. Jesal Shah, Head - Strategy, has resigned from the said post due to personal reasons. Announcement • Aug 22
Alembic Pharmaceuticals Limited Announces That Mr. Nilesh Wadhwa, Head - International Business & Strategy (Formulations Business Development Division), Is Designated as Senior Management Personnel Alembic Pharmaceuticals Limited announced that Mr. Nilesh Wadhwa, Head - International Business & Strategy (Formulations Business Development division), is designated as Senior Management Personnel of the Company effective from 21st August, 2023. Mr. Nilesh Wadhwa has done his B Pharm and MBA (Marketing) from Pune University. He has experience of almost three decades. He was associated with companies such as Blue Cross Laboratories, Solvay Pharmaceuticals, Banner Pharmacaps, Panacea Biotec, Sanofi, Takeda Pharmaceuticals and Johnson & Johnson in various leadership roles. He carries robust experience in strategic business planning, external innovation, business development and commercial excellence. Price Target Changed • Aug 07
Price target increased by 10% to ₹659 Up from ₹598, the current price target is an average from 15 analysts. New target price is 17% below last closing price of ₹794. Stock is up 20% over the past year. The company is forecast to post earnings per share of ₹27.51 for next year compared to ₹17.40 last year. Reported Earnings • Aug 05
First quarter 2024 earnings released: EPS: ₹6.14 (vs ₹3.35 loss in 1Q 2023) First quarter 2024 results: EPS: ₹6.14 (up from ₹3.35 loss in 1Q 2023). Revenue: ₹15.0b (up 19% from 1Q 2023). Net income: ₹1.21b (up ₹1.86b from 1Q 2023). Profit margin: 8.1% (up from net loss in 1Q 2023). The move to profitability was driven by higher revenue. Revenue is forecast to grow 9.8% p.a. on average during the next 3 years, compared to a 9.9% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 47% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Announcement • Jul 24
Alembic Pharmaceuticals Limited to Report Q1, 2024 Results on Aug 04, 2023 Alembic Pharmaceuticals Limited announced that they will report Q1, 2024 results on Aug 04, 2023 Upcoming Dividend • Jul 21
Upcoming dividend of ₹8.00 per share at 1.2% yield Eligible shareholders must have bought the stock before 28 July 2023. Payment date: 03 September 2023. Payout ratio is a comfortable 46% and this is well supported by cash flows. Trailing yield: 1.2%. Lower than top quartile of Indian dividend payers (1.5%). Higher than average of industry peers (0.9%). Reported Earnings • Jun 24
Full year 2023 earnings: EPS exceeds analyst expectations Full year 2023 results: EPS: ₹17.40 (down from ₹26.50 in FY 2022). Revenue: ₹56.5b (up 6.5% from FY 2022). Net income: ₹3.42b (down 34% from FY 2022). Profit margin: 6.1% (down from 9.8% in FY 2022). The decrease in margin was driven by higher expenses. Post-clinical trial products Pre-registration: 66 Approved (during full year): 22 Launched (during full year): 18 Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 12%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 44% per year but the company’s share price has only fallen by 13% per year, which means it has not declined as severely as earnings. Announcement • Jun 06
Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 04, 2023 Alembic Pharmaceuticals Limited, Annual General Meeting, Aug 04, 2023, at 15:00 Indian Standard Time. Reported Earnings • May 06
Full year 2023 earnings: EPS exceeds analyst expectations Full year 2023 results: EPS: ₹17.40 (down from ₹26.50 in FY 2022). Revenue: ₹56.6b (up 6.6% from FY 2022). Net income: ₹3.42b (down 34% from FY 2022). Profit margin: 6.0% (down from 9.8% in FY 2022). The decrease in margin was driven by higher expenses. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 12%. Revenue is forecast to grow 9.9% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 44% per year but the company’s share price has only fallen by 10% per year, which means it has not declined as severely as earnings. Reported Earnings • Feb 04
Third quarter 2023 earnings released: EPS: ₹6.20 (vs ₹8.98 in 3Q 2022) Third quarter 2023 results: EPS: ₹6.20 (down from ₹8.98 in 3Q 2022). Revenue: ₹15.1b (up 19% from 3Q 2022). Net income: ₹1.22b (down 31% from 3Q 2022). Profit margin: 8.1% (down from 14% in 3Q 2022). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 34% per year but the company’s share price has only fallen by 6% per year, which means it has not declined as severely as earnings. Announcement • Feb 02
Alembic Pharmaceuticals Limited Announces Company Secretary and Compliance Officer Changes Alembic Pharmaceuticals Limited announced that Mr. Charandeep Singh Saluja (ICSI Membership No. A28061) has resigned from the position of the Company Secretary & Compliance Officer (Key Managerial Personnel) of the Company with effect from 21st March, 2023 (after the closure of business hours). Ms. Manisha Saraf (ICSI Membership No. A20998) is appointed as the Company Secretary & Compliance Officer (Key Managerial Personnel) of the Company with effect from 1st April, 2023. Ms. Manisha Saraf is an Associate Member of ICSI (Membership No. A20998) with post qualification experience of more than 12 years including 9 years within the Alembic group with experience in corporate secretarial, compliance functions and corporate restructuring under the Companies Act, 2013 and the Listing Regulations. Announcement • Jan 20
Alembic Pharmaceuticals Receives USFDA Tentative Approval for Acalabrutinib Capsules, 100 Mg Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Alembic has a cumulative total of 180 ANDA approvals (157 final approvals and 23 tentative approvals) from USFDA. Announcement • Jan 07
Alembic Pharmaceuticals Limited Receives Final Approval from the US Food & Drug Administration Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency. Buying Opportunity • Dec 20
Now 20% undervalued after recent price drop Over the last 90 days, the stock is down 4.7%. The fair value is estimated to be ₹725, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 6.8% over the last 3 years. Earnings per share has declined by 21%. For the next 3 years, revenue is forecast to grow by 11% per annum. Earnings is also forecast to grow by 36% per annum over the same time period. Announcement • Dec 11
Alembic Pharmaceuticals Limited Receives USFDA Final Approval for DesonideCream, 0.05% Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05%, of Padagis US LLC. Desonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses. Refer to label for full indication. Desonide Cream, 0.05%, has an estimated market size of $12 million for twelve months ending Sep 2022 according to IQVIA. Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA. Announcement • Dec 01
Alembic Pharmaceuticals Receives USFDA Final Approval for Diclofenac Sodium Topical Solution USP, 2% w/w Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w. The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC (Horizon). Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). Announcement • Nov 21
Alembic Pharmaceuticals Receives USFDA Final Approval for Nifedipine Extended-Release Tablets USP, 30 Mg, 60 Mg and 90 Mg Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc. Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical Effort-Associated Angina) and iii) Hypertension. Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of USD 56 million for twelve months ending September 2022 according to IQVIA. Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from USFDA. Reported Earnings • Nov 16
Second quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2023 results: EPS: ₹6.78 (down from ₹8.61 in 2Q 2022). Revenue: ₹14.8b (up 14% from 2Q 2022). Net income: ₹1.33b (down 21% from 2Q 2022). Profit margin: 9.0% (down from 13% in 2Q 2022). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 5.3%. Earnings per share (EPS) missed analyst estimates by 3.1%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 21% per year but the company’s share price has increased by 4% per year, which means it is well ahead of earnings. Board Change • Nov 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 1 experienced director. 7 highly experienced directors. Independent Director Ashok Barat was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Nov 15
Alembic Pharmaceuticals Limited Receives US FDA Final Approval for Cyclophosphamide Capsules, 25 Mg and 50 Mg Alembic Pharmaceuticals Limited announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients. Refer to label for full indication. Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA. Reported Earnings • Nov 13
Second quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2023 results: EPS: ₹6.78 (down from ₹8.61 in 2Q 2022). Revenue: ₹14.8b (up 14% from 2Q 2022). Net income: ₹1.33b (down 21% from 2Q 2022). Profit margin: 9.0% (down from 13% in 2Q 2022). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 5.3%. Earnings per share (EPS) missed analyst estimates by 3.1%. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Pharmaceuticals industry in India. Over the last 3 years on average, earnings per share has fallen by 21% per year but the company’s share price has increased by 5% per year, which means it is well ahead of earnings. Valuation Update With 7 Day Price Move • Nov 03
Investor sentiment improved over the past week After last week's 20% share price gain to ₹659, the stock trades at a forward P/E ratio of 24x. Average forward P/E is 22x in the Pharmaceuticals industry in India. Total returns to shareholders of 20% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at ₹716 per share. Announcement • Nov 03
Alembic Pharmaceuticals Receives Usfda Final Approval for Mesalamine Extended-Release Capsules Usp, 0.375 G Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals Inc. (Salix). Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults. Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of USD 133 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA. Announcement • Nov 02
Alembic Pharmaceuticals Limited to Report Q2, 2023 Results on Nov 11, 2022 Alembic Pharmaceuticals Limited announced that they will report Q2, 2023 results After-Market on Nov 11, 2022 Announcement • Oct 29
Alembic Pharmaceuticals Limited (Alembic) Receives Final Approval from the Us Food & Drug Administration Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval for oncology injection from F-2 Facility (Oncology Injectable) which recently completed the first USFDA inspection.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Taxol Injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL). Paclitaxel Injection, USP is indicated i) as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. ii) for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. iii) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. iv) in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. v) for the second-line treatment of AIDS-related Kaposi's sarcoma. Paclitaxel Injection USP, has an estimated market size of USD 26 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from USFDA. 
