Intimation as per Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 28 November 2024
We would like to inform you that pursuant to Regulation 30 read with Schedule III of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (“SEBI Listing Regulations, 2015”), as amended from time to time, we hereby inform you that the Company has sold clear and marketable titles of land admeasuring approximately 14.38 Acres i.e., 72,358 Sq. yards (hereinafter referred to as “Immovable Property”) located at Mekaguda Gram Panchayat, Nandigama Mandal, Ranga Reddy District, Telangana, India for a total consideration of Rs. 115.57 crore including certain infrastructure cost.
As no business operations of the Company are carried out on the said land and building being sold, the said sale will not have any impact on the business operations of the Company. Further the sale of the said Property does not constitute as an undertaking or substantially the whole of the undertaking for the Company in terms of section 180(1)(a) of the Companies Act, 2013.
The details as required under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 read with SEBI Circular No. SEBI/HO/CFD/CFD-PoD1/P/CIR/2023/123 dated July 13, 2023 are as follows:
| S. No. |
Particulars |
Remarks |
| 1 |
The amount and percentage of the turnover or revenue or income and net worth contributed by such unit or division of the listed entity during the last financial year |
Considering that the sale is of an Immovable Property, the said details are not applicable. |
| 2 |
Date on which the agreement for sale has been entered into |
27th November, 2024 |
| 3 |
The expected date of completion of sale disposal |
27th November, 2024 |
| 4 |
Consideration received from such sale/disposal Consideration is yet to be negotiated and finalized with the potential buyers |
Rs.115,57,50,000/- (Rupees One Hundred Fifteen Crore Fifty Seven Lakh Fifty Thousand only) including certain infrastructure cost. |
| 5 |
Brief details of buyers and whether any of the buyers belong to the promoter/ promoter group/ group companies. If yes, details thereof |
As per the terms of the agreement the details of the buyer are confidential, and the buyer does not belong to Promoter/Promoter Group/Group Companies |
| 6 |
Whether the transaction would fall within related party transactions? If yes, whether the same is done at “arm’s lengthWhether the transaction would fall within related party transactions? If yes, whether the same is done at “arm’s length”td>
| No. This is not a related party transaction |
| 7 |
Whether the sale, lease or disposal of the undertaking is outside Scheme of Arrangement? If yes, details of the same including compliance with regulation 37A of LODR Regulations |
No |
| 8 |
Additionally, in case of a slump sale, indicative disclosures provided for amalgamation/merger, shall be disclosed by the listed entity with respect to such slump sale |
Not Applicable |
NATCO Pharma Files Generic for Risdiplam Oral Solution in the US 21 November 2024
NATCO is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of EVRYSDI (Risdiplam) 0.75 mg/mL For Oral Solution. EVRYSDI® is the brand of Genentech Inc.
NATCO believes it is amongst one of the first two companies to have filed a substantially-complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of shared marketing exclusivity at the time of potential launch of the generic product under certain circumstances. NATCO has been named as one of the defendants in a lawsuit filed in the United States District Court for the District of New Jersey by Genentech, Inc., Hoffmann-La Roche Inc., and PTC Therapeutics, Inc.
EVRYSDI® has recorded sales of USD 571 million in the US market for the year 2023*.
Risdiplam for Oral Solution is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. *brand sales (annual report)
Regulatory Update under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 21 November 2024
With reference to our earlier disclosure dated 30th August, 2023 regarding investment in ISCA, Inc., a Delaware Corporation, we would like to inform you that in accordance with the provisions of Regulation 30 read with Schedule III of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the Company has sold the investment held in M/s. ISCA, Inc., a Delaware Corporation.
The details as required under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
| S. No. |
Particulars |
Details |
| A |
The amount and percentage of the turnover or revenue or income and net worth contributed by such unit or division or undertaking or subsidiary or associate company of the listed entity during the last financial year |
Not Applicable |
| B |
Date on which the agreement for sale has been entered into |
28th August 2024 |
| C |
The expected date of completion of sale/disposal |
19th November 2024 |
| D |
Consideration received from such sale/disposal |
USD 2,061,102.10 (Equivalent to INR 173,895,184.18) |
| E |
Brief details of buyers and whether any of the buyers belong to the promoter/ promoter group/group companies. If yes, details thereof |
“DE SANGOSSE SAS” a Company organized under the laws of France.
Does not belong to the Promoter/Promoter group/group Companies. |
| F |
Whether the transaction would fall within related party transactions? If yes, whether the same is done at “arm’s length” |
No |
| G |
Whether the sale, lease or disposal of the undertaking is outside Scheme of Arrangement? If yes, details of the same including compliance with regulation 37A of LODR Regulations |
No |
| H |
Additionally, in case of a slump sale, indicative disclosures provided for amalgamation/merger, shall be disclosed by the listed entity with respect to such slump sale |
Not Applicable |
NATCO records ₹1434.9 Crore consolidated revenue and INR 676.5 Crore, profit after tax, for Q2 FY25 12 November 2024
NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today announced results for second quarter of FY2025.
NATCO records ₹1434.9 Crore consolidated revenue and INR 676.5 Crore, profit after tax, for Q2 FY25
NATCO recorded consolidated total revenue of INR 1434.9 Crore for the second quarter of FY2025 that ended on 30th
September 2024, as against INR 1060.8 Crore for the same period last year, reflecting a growth of 35.3%. The net profit for
the period, on a consolidated basis, was INR 676.5 Crore as against INR 369.0 Crore same period last year, showing robust
growth of about 83%.
The company has shown continued strong growth during the second quarter driven by exports formulation business and
stable domestic pharma business.
The Board of Directors has declared second interim dividend of INR 1.50 per equity share, for FY 2024-25.
| Segment |
Q1FY25
|
Q2FY25 |
Q2FY24 |
| Active Pharmaceutical Ingredients (API) |
49.6
|
39.2
|
77.8
|
| Formulations, Domestic |
102.3 |
102.2 |
102.5 |
|
Formulations, Export (Incl. profit share and subs)
|
1211.3
|
1210.1
|
792.3
|
Other operating and non-operating income
| 57.6 |
43.6 |
32.4 |
| Crop Health Sciences (CHS) |
14.1 |
15.6 |
55.8 |
| Total |
1434.9 |
1410.7 1060.8 |
1060.8 |
About NATCO Pharma Limited
NATCO Pharma Limited (www.natcopharma.com), (NSE:NATCOPHARM, BSE: 524816, Reuters: NATP.NS, Bloomberg:
NTCPH,) headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals,
specialty pharmaceuticals, active pharma ingredients and crop protection products. The Company is a R&D oriented, and a
science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition
molecule in the US. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US
FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets. For more information, please visit us
at www.natcopharma.com
Regulatory Update under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 07 October 2024
We would like to inform you that the following
Regulatory Update in accordance with the provisions of Regulation 30 of the SEBI (Listing
Obligations and Disclosure Requirements) Regulations, 2015:
NATCO Pharma Limited announces that Mylan Pharmaceuticals Inc. and Novo Nordisk have
reached a settlement of the U.S. patent litigation related to generic Ozempic (Semaglutide).
NATCO and Mylan are partnered on the development of generic Ozempic products. The terms
of the settlement are confidential.
NATCO’s manufacturing partner is Stelis.
NATCO Pharma (Canada) Inc. announces US$ 8 million investment in eGenesis, Inc. 04 September 2024
NATCO Pharma (Canada) Inc. announces US$ 8 million investment in eGenesis, Inc.
NATCO Pharma Limited is pleased to announce that its wholly owned Canadian subsidiary, NATCO
Pharma (Canada) Inc., has made an investment of US$ 8 million in eGenesis, Inc., a biotechnology company at the forefront of xenotransplantation focused on developing safe and effective human-
compatible organs for transplant.
In March 2024, eGenesis announced the world’s first porcine kidney transplant in a living patient. The
transplant was authorized by the U.S. Food & Drug Administration (FDA) under the Expanded Access
pathway.
eGenesis is pioneering a genome engineering-based approach in the development of safe and effective
transplantable organs to end the global organ shortage and transform the treatment of organ failure.
The eGenesis Genome Engineering and Production (EGENTM) Platform is the only technology of its kind
to comprehensively address cross-species molecular incompatibilities and viral risk via genetic
engineering to improve the lives of patients in need of a transplant. eGenesis is advancing
development programs for kidney transplant, acute liver failure, and heart transplant.
“We are excited to get involved with eGenesis, Inc. with respect to their pioneering work in
xenotransplantation. We agree with the vision of eGenesis that xenotransplantation technology has
the potential to end the global transplant shortage and transforming the treatment of organ failure by
eliminating waitlist mortality,” said Rajeev Nannapaneni, Vice Chairman and CEO of NATCO Pharma
Limited.
“We are thrilled to welcome NATCO as an investor. Their support will be used in advancing our research
and bringing our innovative therapies to market,” said Mike Curtis, CEO of eGenesis, Inc.
About NATCO Pharma Limited
NATCO Pharma Limited is a vertically integrated pharmaceutical company headquartered in
Hyderabad, India. With a strong focus on research and development, NATCO Pharma is dedicated to
delivering high-quality, affordable medicines to patients worldwide.
About eGenesis, Inc.
eGenesis, Inc. is a biotechnology company based in Cambridge, Massachusetts, USA, focused on using
its multiplex gene editing and genome engineering platform to transform solid organ and therapeutic
cell transplantation for the treatment of serious diseases.
Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015
Investment of US$ 8 million in eGenesis, Inc. by NATCO Pharma (Canada) Inc., Subsidiary Company
of NATCO Pharma Limited
| Sl.
No. |
Particulars
|
Details of Investment |
| A |
Name of the target entity, details in
brief such as size, turnover etc.
|
1) Name of the target entity
eGenesis, Inc.
2) Details in brief such as size, turnover etc.
It is an R&D company engaged in using its
multiplex gene editing and genome
engineering platform to research and develop
solid organ and therapeutic cell
transplantation for the treatment of serious
diseases |
| B |
Whether the acquisition would fall
within related party transaction(s) and
whether the promoter/ promoter
group/ group companies have any
interest in the entity being acquired? If
yes, nature of interest and details
thereof and whether the same is done
at “arm’s length” |
No
|
|
C
|
Industry to which the entity being
acquired belongs |
Biotechnology |
| D |
Objects and effects of acquisition
(including but not limited to,
disclosure of reasons for acquisition of
target entity, if its business is outside
the main line of business of the listed
entity) |
Investing in new-age therapeutic programmes
addressing critical unmet medical needs |
| E |
Brief details of any governmental or
regulatory approvals required for the
acquisition |
NA |
| F |
Indicative time period for completion
of the acquisition; |
September 30, 2024 |
| G |
Nature of consideration - whether
cash consideration or share swap and
details of the same |
Cash consideration |
| H |
Cost of acquisition or the price at
which the shares are acquired |
4,06,29,761 shares |
| J |
Brief background about the entity
acquired in terms of products/line of
business acquired, date of
incorporation, history of last 3 years
turnover, country in which the
acquired entity has presence and any
other significant information (in brief) |
1. Brief background:
It is engaged in using its multiplex gene editing
and genome engineering platform to
transform solid organ and therapeutic cell
transplantation for the treatment of serious
diseases.
2. Line of business:
Biotechnology
3. Date of incorporation:
October 1, 2015
4. Turnover of last 3 years ending December
31 (in US$ million):
Nil
5. Country in which the acquired entity will
have presence:
United States of America |
NATCO records ₹1410.70 Crore consolidated revenue and ₹668.50 Crore of profit, after tax, for the First Quarter, FY2024-25 12 August 2024
Ref: PR/02/2024-25 27th May, 2024
NATCO records ₹1410.70 Crore consolidated revenue and ₹668.50 Crore of profit, after tax, for the First Quarter, FY2024-25
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of ₹1410.70 Crore for the first quarter ended on 30th June 2024, as against ₹1160.2 Crore for the same period last year, reflecting a growth of 21.6% in revenue. The net profit for the period, on a consolidated basis, was ₹668.50 Crores as against ₹420.3 Crore same period last year, showing 59% growth in profits.
The growth in revenue and profits were driven primarily by exports formulation business. Segmental Revenue Split (All Figures in ₹ Crore)-
Segmental Revenue Split (All Figures in INR Crore)
| Segment |
Revenue,
Q1 FY25
|
Revenue,
Q4 FY24 |
Revenue,
Q1 FY24
|
| API |
39.2
|
50.0 |
75.1 |
| Formulations, Domestic |
102.2 |
52.4
|
132.4 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
1210.10 |
954.9 |
884.2
|
| Other Operating income &
non-operating income |
43.6 |
53.4 |
23.8 |
| Crop Health Sciences (CHS) |
15.6 |
(0.4) |
44.7 |
| TOTAL |
1410.7 |
1110.3 |
1160.2 |
The Board of Directors has declared an interim dividend of ₹3.0 per equity share of ₹2.0 each, during Q1 of FY2025.
For NATCO Pharma Limited
Ch. Venkat Ramesh
Company Secretary &
Compliance Officer
Natco Pharma Limited announces submission of Abbreviated New Drug Application 31 May 2024
NATCO Pharma Limited announces submission of
Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the
U.S. Food and Drug Administration (FDA) for the generic version of Rimegepant Sulfate tablet
Eq 75mg base strength. Rimegepant is currently indicated for the acute treatment of migraine
with or without aura in adults and for the preventive treatment of episodic migraine in adults.
Rimegepant Sulfate tablets are marketed in the United States (US) by Pfizer Inc. under the
brand name NURTEC ODT®. Natco has been named as defendant in a lawsuit filed in the
United States district court for the district of Delaware by Pfizer Inc. and Pfizer Ireland
pharmaceuticals. We believe that our ANDA may be eligible for 180 days of marketing
exclusivity at the time of potential launch of the product under certain circumstances.
NURTEC ODT® has recorded sales of USD 908 million in the US market for the year ending
December 2023, as per Pfizer financial results presentation.
NATCO records INR 4,126.9 Crore consolidated revenue and INR 1,388.3 Crore of profit after tax for the year ended March 31st, 2024 27 May 2024
Ref: PR/02/2024-25 27th May, 2024
NATCO records INR 4,126.9 Crore consolidated revenue and INR 1,388.3 Crore of profit after tax for the year ended March 31st, 2024
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 4,126.9 Crore for the year ended on 31st March, 2024, as against INR 2,811.7 Crore for the last year, reflecting 46.8% growth. The net profit for the period, on a consolidated basis, was INR 1,388.3 Crore, as against INR 715.3 Crore last year showing a growth rate of 94.1%.
The company has recorded its highest ever consolidated revenue and profits during this financial year. This is the result of decades of our diligence. On the domestic business front, the company has taken a one-time charge of approximately INR 90.0 Crore which is reflected in revenue and profitability numbers. There were three aspects of this one-time charge-
- In Pharma formulations domestic business, we charged and accounted for a return of stock from super-stockist to C&Fs amounting to about INR 35.0 Crore due to change in our business model
- On the Crop Health Sciences (CHS) business, due to poor crop season the stock returns were more than expected by INR 25.0 Crore
- Provisions on assets of CHS division amounted to about INR 30.0 Crore. This was done due to non-utilization of certain assets used for manufacturing of Agro intermediates.
For the fourth quarter (Q4) ended March 31st, 2024, the company recorded a net revenue of INR 1,110.3 Crore, on a consolidated basis, as against INR 926.9 Crore during Q4, FY 2023. The profit for the fourth quarter, on a consolidated basis, was INR 386.3 Crore, as against INR 275.8 Crore same period last year.
Segmental Revenue Split (All Figures in INR Crore)
| Segment |
Q4 FY24
|
FY24
|
| API |
50.0
|
249.2 |
| Formulations, Domestic |
52.4 |
386.7 |
| Formulations, Exports
(incl. Profit Share &
Foreign Subs) |
954.9 |
3,236.9 |
| Other Operating income &
non-operating income |
53.4.4 |
145.8 |
| Crop Health Sciences
(CHS) |
(0.4)
|
108.3 |
| TOTAL |
1,110.3 |
4126.9 |
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 23 April 2024
With reference to the above cited subject and further to our earlier intimation dated November 2, 2023 about the successful completion of United States Food and Drug Administration’s (USFDA) inspection of the firm’s compliance to Pharmacovigilance requirements with zero observations, we bring to your notice that the Company is in receipt of the Establishment Inspection Report (EIR) from USFDA concluding the inspection as Closed.
Fresenius Files Complaint Against Natco Pharma USA LLC Regarding Diazepam Injection Prefilled Syringe Marketing 18 April 2024
Ref: PR/01/2024-25
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to update that Fresenius
Kabi USA, LLC and Fresenius Kabi Deutschland GmbH (together, “Fresenius”) have filed a complaint
against Natco Pharma USA LLC f/k/a Dash Pharmaceuticals LLC in the District Court of Delaware
relating to the marketing of Dash Pharmaceuticals Diazepam Injection prefilled syringe in the
United States. Fresenius has not yet effectuated service of the complaint which is required to
commence the lawsuit.
Natco Pharma intends to defend the matter accordingly.
Dash Pharmaceuticals LLC had been acquired by Natco Pharma, Inc. and Dash Pharmaceuticals LLC
had changed its name to Natco Pharma USA LLC.
Update on USFDA inspection at Natco’s manufacturing facility in Kothur, Telangana 09 April 2024
Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 and in furtherance to our intimation dated 19th October 2023 on the routine current Good Manufacturing Practices (cGMP) inspection at our Kothur (Pharma Division) manufacturing facility.
We wish to inform you that the Company has received a Warning Letter dated 8th April, 2024 from the United States Food and Drug Administration (USFDA). The Company does not believe that the Warning Letter will have an impact on disruption of supplies or existing revenues from this facility. It may cause delay/withholding of pending product approvals from this site.
The Company will respond to the Warning Letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance. The Company also remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.
Update on Intimation under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 14 February 2024
In compliance with SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, further to our earlier intimation dated 7th December 2023, we would like to inform that the operations at the Company's factory located at Manali Industrial Area, Chennai, Tamil Nadu have been restarted which are earlier disrupted due to cyclone with flooding / water logging of the factory premises. There is no material impact on the operations and financial position of the Company.
NATCO records INR 795.6 Crore consolidated revenue and INR 212.7 Crore of profit, after tax, for the Third Quarter, FY2024 14 February 2024
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 795.6 Crore, for the Third quarter ended on 31stDecember, 2023, as against INR 513.3 Crore for the same period last year, reflecting a growth of 55%. The net profit for the period, on a consolidated basis, was INR 212.7 Crore as against INR 62.3 Crore during the same period last year.
The company has shown strong growth across businesses compared to last year and is confident of its strategy going forward. For 9 months ending December 31st, 2023, the company recorded total revenue of INR 3016.6 Crore as against INR 1884.8 Crore for same period last year. Similarly, the net profit for 9 months, the company recorded INR 1002.0 Crore as against INR 439.5 Crore in the same period last year.
Segmental Revenue Split (All Figures in INR Crore)- Segment
Revenue,
Q3 FY24
Revenue,
Q2 FY24
Revenue,
Q3 FY23
API
46.3
77.8
42.6
Formulations, Domestic
99.4
102.5
101.1
Formulations, Exports (incl. Profit Share & Foreign Subs)
605.6
792.3
333.7
Other Operating income & non-operating income
30.2
32.4
26.0
Crop Health Sciences (CHS)
14.1
55.8
9.9
TOTAL
795.6
1060.8
513.3
NATCO records ₹1160.2 Crore consolidated revenue and ₹420.3 Crore of profit, after tax, for the First Quarter, FY2023-24
Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 07 February 2024
Scrip Code: 524816 Scrip Code: NATCOPHARM
| Sl. No. |
Particulars |
Details of Investment |
| A |
Name of the target entity, details in brief such as size, turnover etc.
|
1) Name of the target entity Eywa Pharma Pte Ltd
2) Details in brief such as size, turnover etc. Eywa Pharma Pte Ltd is incorporated out of Singapore. For the year ended December 31, 2023, the consolidated gross revenue is US$ 19.16 million. |
| B |
Whether the acquisition would fall within related party transaction(s) and whether the promoter/ promoter group/ group companies have any interest in the entity being acquired? If yes, nature of interest and details thereof and whether the same is done at “arm’s length” |
No |
| C |
Industry to which the entity being acquired belongs |
Pharmaceuticals |
| D |
Objects and effects of acquisition (including but not limited to, disclosure of reasons for acquisition of target entity, if its business is outside the main line of business of the listed entity) |
The Company is engaged in the business of pharmaceuticals. Investment of US$ 3 million originally made on January 13, 2023 for 2.80% shareholding on a fully diluted basis. Now the shares are allotted on account of anti-dilution rights making the shareholding to 7.07% on a fully diluted basis. |
| E |
Brief details of any governmental or regulatory approvals required for the acquisition
|
Under Foreign Exchange Management (Overseas Investment) Rules, 2022 and subject to applicable regulatory approvals, if any |
| F |
Indicative time period for completion of the acquisition; |
Not applicable |
| G |
Nature of consideration - whether cash consideration or share swap and details of the same |
Cash consideration of US$ 3 million earlier invested on January 13, 2023
|
| H |
Cost of acquisition or the price at which the shares are acquired |
7.07% shareholding (Increase is on account of anti-dilution shares receivable to protect the investment value of approximately US$ 3 million already made) |
| I |
Percentage of shareholding / control acquired and / or number of shares acquired |
7.07% shareholding |
| J |
J
brief background about the entity acquired in terms of products/line of business acquired, date of incorporation, history of last 3 years turnover, country in which the acquired entity has presence and any other significant information (in brief)
|
1. Brief background:
Eywa Pharma Pte Ltd sells pharmaceutical formulations.
2. Line of business:
Pharmaceuticals
3. Date of incorporation:
May 13, 2015
4. Turnover of last 3 years ending December 31 (in US$ million):
For the year 2023: 19.16
For the year 2022: 27.01
For the year 2021: 25.05
5. Country in which the acquired entity has presence:
Singapore
|
NATCO Pharma Limited invests around US$ 2 million in Cellogen Therapeutics Private Limited 18 January 2024
Ref: PR/09/2023-24
Cellogen Therapeutics Private Limited, a Delhi based biotech startup promoted by Dr. Gaurav
Kharya, Director, Centre for Bone Marrow Transplant & Cellular Therapy, Indraprastha Apollo
Hospital, Delhi has raised around US$ 2 million from NATCO Pharma Limited. Cellogen is primarily
involved in two R&D programs involving cell and gene therapy solutions.
Chimeric Antigen Receptor T (CAR T) cell therapy program is at an advanced stage for Cellogen
Therapeutics where the T cells of the patients are genetically engineered to identify and kill the
cancer cells. Cellogen Therapeutics has developed bi-specific CARs and also added another co-
stimulatory domain to increase the efficacy and persistence of the CAR in human body as
compared to currently available CAR constructs that are mono-specific with one co-stimulatory
domain. Both these innovations are aimed at reducing the risk of relapse post CAR T cell therapy
which remains a major challenge with existing CAR constructs. Current available products in
market cost around US$ 500,000 – 700,000 which Cellogen aims to bring down to US$ 60,000 –
70,000.
Another program on which Cellogen Therapeutics is working is gene therapy program for
transfusion dependent thalassemia and sickle cell disease. It is noteworthy that these two diseases
form the largest burden of red cell disorders across the globe. As per rough estimates, 40,000 kids
are born each year with these disorders in India (10,000 with thalassemia and 30,000 with sickle
cell disease).
“Cellogen has been working on its next generation CAR T programme for around 2.5 years and has
been able to zero on one particular CAR construct amongst around 40 such constructs. After
successful pre-clinical data using the selected CAR, Cellogen intends to start phase 1 clinical trial
in the first half of 2024. Just like the CAR T cell therapy, Cellogen Therapeutics also intends to bring
gene therapy solutions at affordable cost to our patients in need,” said Dr. Gaurav Kharya, Founder
& Director of Cellogen Therapeutics.
Sri Rajeev Nannapaneni, Director & CEO, NATCO Pharma Limited states, “Cellogen’s area of
research work involving innovative and cost-effective cell and gene therapies for addressing
various oncological, hematological and metabolic diseases is in line with our core value of
providing advanced healthcare with affordability and is basis of our investment thesis. We are
excited about these therapies and pleased to partner with Cellogen Therapeutics.”
Record Date Intimation 14 November 2023
14th November, 2023
Corporate Relationship Department
M/s. BSE Ltd.
Dalal Street, Fort
Mumbai - 400 001.
Scrip Code: 524816
Dear Sir/Madam,
Telangana, INDIA. Tel: +91 40 23547532, Fax: +91 40 23548243
CIN : L24230TG1981PLC003201, www.natcopharma.co.in
The Manager - Listing
M/s. National Stock Exchange of India Ltd.
Exchange Plaza, Bandra-Kurla Complex
Bandra(E), MUMBAI -400 051.
Scrip Code: NATCOPHARM
Sub:- RECORD DATE
The Board of Directors of the Company at their meeting held today have Declared second interim dividend of Rs.1.25/- (Rupees one and paise twenty five only) (62 .50%) each per equity share of Rs.2/- (Rupees two only) each for the financial year 2023-24. The date for taking on record of its shareholders eligible for the purpose of payment of second interim dividend i.e., record date is fixed as Friday, the 24th day of November, 2023. The payment of said interim dividend will start from 1st December, 2023.
Thanking you
Yours faithfully,
For N TCO Pharma Limited
Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) 14 November 2023
November 14, 2023
Corporate Relationship Department Manager – Listing
M/s. BSE Ltd. M/s. National Stock Exchange of India Ltd
Dalal Street, Fort “Exchange Plaza”, Bandra – Kurla Complex
Mumbai 400 001 Bandra (E) Mumbai 400 051
Scrip Code: 524816 Scrip Code: NATCOPHARM
Dear Sir/Madam,
Please find enclose herewith the disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 for your information.
Thanking you,
Ref: PR/07/2023-24 Press Release
Hyderabad, 14th November, 2023
NATCO records ₹1060.8 Crore consolidated revenue and ₹369 Crore of profit after tax, for the Second Quarter, FY2024
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) recorded
consolidated total revenue of ₹1060.8 Crore for the Second quarter of FY2024 that ended
on 30th September 2023, as against ₹452.6 Crore for the same period last year, reflecting a
growth of 134%. The net profit for the period, on a consolidated basis, was ₹369 Crores as
against ₹56.8 Crore same period last year, showing significant growth.
The company business was strong during the quarter due to growth in formulation exports
and increased sales in domestic agrochemical business.
Segmental Revenue Split (All Figures in ₹ Crore)-
| Segment |
Revenue,
Q2 FY24 |
Revenue, Q1 FY24 |
Revenue, Q2 FY23 |
| API |
77.8 |
75.1 |
44.1 |
| Formulations, Domestic |
102.5 |
132.4 |
93.5 |
| Formulations, Exports
(incl. Profit Share &
Foreign Subs) |
792.3 |
884.2 |
283.4 |
| Other Operating income &
non-operating income |
32.4 |
23.8 |
28.6 |
| Crop Health Sciences
(CHS) |
55.8
|
44.7 |
3.0 |
| TOTAL |
1060.8 |
1160.2 td>
| 452.6 |
The Board of Directors had declared second interim dividend of ₹ 1.25 per equity share of
₹2.0 each, for FY 2024.
USFDA Completes Pharmacovigilance inspection at the NATCO Corporate Office 02 November 2023
NATCO Pharma Limited is pleased to announce the successful completion of United States
Food and Drug Administration’s (USFDA) inspection of the firm’s compliance to
Pharmacovigilance requirements with zero observations.
NATCO’s Pharmacovigilance Department, at its Corporate Office in Hyderabad, was inspected
from October 30, 2023 to November 1, 2023. The Pharmacovigilance procedures of NATCO
for its products marketed globally and particularly, in USA, were inspected and found to
comply with USFDA’s requirements.
USFDA Completes Inspection of NATCO’s Kothur Pharma Division 19 October 2023
Natco Pharma Limited would like to announce the completion of an inspection by the United
States Food and Drug Administration (USFDA) for its Pharma Division located in Kothur
Hyderabad, India, which was conducted from 9th October, 2023 to 18th October, 2023.
At the end of the inspection, the facility received Eight (8) observations. The company is
confident of addressing all the observations within the stipulated time and working with
USFDA to close them at the earliest.
Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 30 August 2023
Scrip Code: 524816
Scrip Code: NATCOPHARM
Please find enclose herewith the disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 for your information.
Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
Particulars:
Name of the target entity, details in brief such as size, turnover etc.
Details of Investment:
ISCA, Inc., a Delaware Corporation had a turnover of $9,338,426 in the last fiscal year ending on December 31, 2022.
Particulars:
Whether the acquisition would fall within related party transaction(s) and whether the promoter/ promoter group/ group companies have any interest in the entity being acquired? If yes, nature of interest and details thereof and whether the same is done at “arm’s length”
Details of Investment:
NO
--------
Particulars:
Industry to which the entity being acquired belongs
Details of Investment:
Pest control for agriculture
--------
Particulars:
Objects and effects of acquisition (including but not limited to, disclosure of reasons for acquisition of target entity, if its business is outside the main line of business of the listed entity)
Details of Investment:
Strategic investment for bio control of pest
--------
Particulars:
Brief details of any governmental or regulatory approvals required for the acquisition
Details of Investment:
Under Foreign Exchange Management (Overseas Investment) Rules, 2022 and subject to applicable regulatory approvals, if any.
--------
Particulars:
Indicative time period for completion of the acquisition;
Details of Investment:
31 August 2023
--------
Particulars:
Nature of consideration - whether cash consideration or share swap and details of the same
Details of Investment:
Cash consideration
--------
Particulars:
Cost of acquisition or the price at which the shares are acquired
Details of Investment:
Overall cost of acquisition is USD 2 million
--------
Particulars:
Percentage of shareholding / control acquired and / or number of shares acquired
Details of Investment:
5.79% (Increase is on account of anti-dilution shares receivable to protect the investment value of approximately USD 2 million already made, with only a nominal cash outflow now)
--------
Particulars:
Brief background about the entity acquired in terms of products/line of business acquired, date of incorporation, history of last 3 years turnover, country in which the acquired entity has presence and any other significant information in brief)
Details of Investment:
» Brief background: ISCA, Inc. aims to manufacture pesticides that disrupt mating patterns in pests and thereby control insect populations.
» Line of business: Pest control for agriculture
» Date of incorporation: 7th November, 2019
» Turnover of last 3 years ending December 31 (in US$):
•Turnover as of December 31, 2022: $9,338,426
•Turnover as of December 31, 2021: $9,016,200
•Turnover as of December 31, 2020: $9,714,611
» Country in which the acquired entity will have presence: USA
--------
NATCO records ₹1160.2 Crore consolidated revenue and ₹420.3 Crore of profit, after tax, for the First Quarter, FY2023-24 09 August 2023
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of ₹1160.2 Crore for the first quarter ended on 30th June 2023, as against ₹918.9 Crore for the same period last year, reflecting a growth of 26.3%. The net profit for the period, on a consolidated basis, was ₹420.3 Crores as against ₹320.4 Crore same period last year, showing 31.2% growth.
The company had made a provision of ₹51.0 Crore towards pending patent infringement litigation cases for its products in India (without admission of either liability for infringement or validity of such patents) and also incurred about ₹17.0 Crore towards special incentive to employees.
Major drivers of business during the quarter were from formulation exports, strong growth in domestic business of both Pharma and Agro, and steady sales from subsidiaries.
Segmental Revenue Split (All Figures in ₹ Crore)-
| Segment |
Revenue,
Q1 FY24 |
Revenue,
Q4 FY23 |
Revenue,
Q1 FY23 |
| API |
75.1 |
72.8 |
50.8 |
| Formulations, Domestic |
132.4 |
91.8 |
88.5 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
884.2 |
709.2 |
736.9 |
| Other Operating income & non-operating income |
23.8 |
26.1 |
41.7 |
| Crop Health Sciences (CHS) |
44.7 |
27.0 |
1.0 |
| TOTAL |
1160.2 |
926.9 |
918.9 |
The Board of Directors has declared an interim dividend of ₹7/- (350%) per equity share of ₹2/- each, for the FY2024.
NATCO files generic Erdafitinib Tablets in USA 26 July 2023
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths.
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib Tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa®. NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech Inc. and Otsuka holdings Co.’s Astex Therapeutics Ltd.
NATCO believes that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch.
Balversa® has recorded sales of USD 36.5 million in the US market for the year ending December 2022, as per IQVIA database.
NATCO receives final approval for Tipiracil Hydrochloride and Trifluridine (generic for Lonsurf®) for the US market 16 June 2023
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval for its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf®) from the U.S. Food and Drug Administration (USFDA). Lonsurf® is sold in the US by Taiho Oncology Inc.
Natco believes it is one of the First-to-File for the product and may be eligible for a 180-day exclusivity at the time of launch. Lonsurf® is indicated primarily for the treatment of colorectal cancer. As per IQVIA data, Lonsurf® had generated annual sales of $211 million in USA during the twelve months ending December 2022.
NATCO’s VIZAG Formulation facility receives establishment inspection Report (EIR) 15 June 2023
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection and received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its drug formulations manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh, India, for an inspection conducted during the period from 30th January to 3rd February 2023.
NATCO records INR 2811.7 Crore consolidated revenue and INR 715.3 Crore of profit after tax, for the year ended 31st March, 2023. 29 May 2023
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2811.7 Crore for the year ended on 31st March, 2023, as against INR 2043.8 Crore for the last year, reflecting 37.6% growth. The net profit for the period, on a consolidated basis, was INR 715.3 Crore, as against INR 170.0 Crore last year.
The increase in revenue and profits for the year was driven by business growth in the US market and growth in our subsidiaries in Canada & Brazil. Our Crop Health Division started off well with strong growth potential in ensuing years.
For the fourth quarter (Q4) ended March 31st, 2023, the company recorded a net revenue of INR 926.9 Crore, on a consolidated basis, as against INR 610.6 Crore during Q4, FY 2022. The profit for the fourth quarter, on a consolidated basis was INR 275.8 Crore, as against a loss of INR 50.5 Crore last year fourth quarter.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue, Q4 FY23 |
Revenue,
Full Year FY23 |
| API |
72.8 |
210.3 |
| Formulations, Domestic |
91.8 |
374.9 |
| Formulations, Exports (incl.
Profit Share & Foreign Subs) |
709.2 |
2063.2
|
| Other Operating income & non-operating income |
26.1 |
122.4 |
| Crop Health Sciences (CHS) |
27.0 |
40.9 |
NATCO launches generic Pomalidomide Capsules in Canada 01 March 2023
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces launch of Pomalidomide Capsules in Canada, the first generic alternative to POMALYST® brand in the country approved by Health Canada. Pomalidomide is used in combination with Dexamethasone and Bortezomib for the treatment of adult patients with multiple myeloma. Multiple myeloma, commonly referred to as myeloma, is a cancer of plasma cells. It is the second most common form of blood cancer in Canada with about 8,000 Canadians living with myeloma.
Natco launched pomalidomide under their brand NAT-POMALIDOMIDE in strengths of 1 mg, 2 mg, 3 mg and 4 mg capsules and available through the RevAid® risk management platform. This launch reflects Natco’s continued investment in Canada to expand portfolio of high-quality generic medicines at affordable prices.
RevAid® and POMALYST are trademarks of Celgene Corporation.
NATCO files generic Olaparib Tablets in USA 13 February 2023
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Olaparib Tablets 100mg and 150mg.
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer. Olaparib Tablets are marketed in the United States (US) by AstraZeneca under brand Lynparza®. NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by AstraZeneca and Kudos Pharmaceuticals.
NATCO and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch of the product.
Lynparza® has recorded sales of USD 1,226 million in the US market for the year ending December 2022, as per AstraZeneca results presentation.
Lynparza® is a registered trademark of the AstraZeneca group of companies
NATCO records INR 513.3 Crore consolidated revenue and INR 62.3 Crore of profit, after tax, for the Third quarter, FY2022·23 09 February 2023
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.3 Crore, for the Third quarter ended on 31" December, 2022, as against INR 590.7 Crore for the same period last year that had a one-time licensing revenue. The net profit for the period, on a consolidated basis, was INR 62.3 Crores as against
INR 80.4 Crore same period last year.
For 9 months ending December 31", 2022, the company recorded total revenue of INR 1884.8 Crore as against INR 1433.2 Crore for same period last year and on the net profit side, the company recorded INR 439.5 Crore as against INR 220.5 Crore.
Segmental Revenue Split (All Figures In INR Crore)
| Segment |
Revenue, Q3 FY23 |
Revenue, Q2 FY23 |
Revenue, Q3 FY22 |
| API |
42.6 |
44.1 |
61.7 |
| Formulations, Domestic |
101.1 |
93.5 |
100.3 |
| Formulations, Export (incl. Profit Sharing & Foreign Subs) |
333.7 |
283.4 |
383.1 |
| Other Operating income & non-operating income |
26.0 |
28.6 |
45.3 |
| Crop Health Sciences (CHS) |
9.9 |
3.0 |
0.3 |
| TOTAL |
513.3 |
452.6 |
590.7 |
The Board of Directors has declared 3rd interim dividend of INR 1.25 per equity share, for FY 2022-23.
Nuvama Wealth Management invites you to Natco Pharma Q3 FY23 Earnings call 06 February 2023
We are organising a conference call with the management of Natco Pharma to discuss the Company’s Q3 FY23 financial results on Friday, February 10, 2023 at 11.00 AM IST.
Mr. Rajeev Nannapaneni, Director & Chief Executive Officer and Mr. Rajesh Chebiyam, Executive Vice President – Crop Health Sciences will represent Natco Pharma on the call.
Click here for more information
USFDA Completes Inspection of Natco’s Vizag Formulation Facility 04 February 2023
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to announce the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Ramky SEZ, near Visakhapatnam (Vizag), India, which was conducted during the period 30th January, 2023 to 3rd February, 2023.
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure.
Natco receives favourable judgement, FMC appeal dismissed 05 December 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that Double Bench of the Hon'ble High Court of Delhi has dismissed an appeal filed by FMC Corporation, FMC Singapore and FMC India and has upheld prima facie the Judgement of the Hon'ble Single Judge that the Natco Chlorantraniliprole (CTPR) Process does not infringe FMC's Indian Patent 298645.
Legal Update 16 November 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to update that the Appeals Court in the US has rejected its marketing partner Alvogen’s appeal on Ibrutinib Tablets of 140 mg, 280 mg, 420 mg and 560 mg strength (proposed generic equivalents to Imbruvica® Tablets).
Natco and its co-development & marketing partner, Alvogen Pine Brook LLC, USA, are assessing their option on the way forward
Legal Update 12 November 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to update that Bristol Myers Squibb, Teva, and Natco have been named defendants in an antitrust lawsuit in the US by Walgreens Co. regarding Lenalidomide (Revlimid). Natco believes this matter is without merit. Teva is the ANDA holder and front-end marketing partner for the generic product in the US.
NATCO records Rs 452.6 Crore consolidated revenue and Rs 56.8 Crore of profit after tax, for the Second Quarter, FY2022-23 10 November 2022
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of Rs 452.6 Crore for the Second quarter of FY2023 that ended on 30th September 2022, as against Rs 415.2 Crore for the same period last year, reflecting a growth of 9%. The net profit for the period, on a consolidated basis, was Rs 56.8 Crores as against Rs 65.1 Crore same period last year.
During the second quarter, profit share associated with export sales of Lenalidomide product to United States was minimal. Pharma domestic formulations business showed growth. In Crop Health Sciences division, Chlorantraniliprole (CTPR) associated key products were launched which is expected to boost growth in near future.
Segmental Revenue Split (All Figures in Rs Crore)
|
Revenue, Q2 FY23 |
Revenue, Q1 FY23 |
Revenue, Q2 FY22 |
| API |
44.1 |
50.8 |
76.3 |
| Formulations, Domestic |
93.5 |
88.5 |
99.8 |
| Formulations, Export (incl. Profit Sharing & Foreign Subs) |
283.4 |
736.9 |
190.5 |
| Other Operating income & non-operating income |
28.6 |
41.7 |
45.1 |
| Crop Health Sciences (CHS) |
3 |
1 |
3.5 |
| TOTAL |
452.6 |
918.9 |
415.2 |
The Board of Directors has recommended a second interim dividend of Rs 0.75 per equity share of Rs 2.0
each, for FY 2022-23.
NATCO Announces Launch of First Generic Version of Pomalyst® (Pomalidomide) Capsules in the Australian Market 09 November 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of first generic version of Pomalyst® (Pomalidomide) Capsules in 1,2,3,4 mg strengths in the Australian market. The product was launched by NATCO’s commercial partner Juno Pharmaceuticals Pty Ltd.
Pomalidomide is prescribed for treatment of Multiple Myeloma and Kaposi Sarcoma. For more information refer to the full prescribing information or other medical resources.
Pomalyst® registered sales of USD 35.6 million in the Australian market for the year ending 31st March 2022 as per industry sales data.
Pomalyst ® is a registered trademark of Celgene/BMS. All brand names and trademarks are the property of their respective owners.
Nuvama Wealth Management invites you to Natco Pharma Q2 FY23 Earnings call 03 November 2022
Nuvama Wealth Management is hosting a conference call with the management of Natco Pharma to discuss the Company’s Q2FY23 financial results on Friday, November 11, 2022 at 11.00 AM IST. Mr. Rajeev Nannapaneni, Director & Chief Executive Officer and Mr. Rajesh Chebiyam, Executive Vice President – Crop Health Sciences will represent Natco Pharma on the call.
Click here for more information
Legal update 21 October 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to inform that FMC Corporation and FMC Singapore have served a copy of appeal on Natco. The Appeal is against the well-reasoned and clear judgement of the Hon'ble High Court of Delhi dated 19th September, 2022 which enabled Natco to launch its CTPR (Chlorantraniliprole) products.
Natco is confident of its case and is confident of its success in the appeal.
NATCO launches Chlorantraniliprole (CTPR) combination Agro Products in India 04 October 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce launch of two Chlorantraniliprole (CTPR) pesticide formulated combination products under the brand names:
a. NATVOL: Chlorantraniliprole 8.8% + Thiamethoxam 17.5% SC; and
b. NATLIGO: Chlorantraniliprole 9.3% + Lambda-cyhalothrin 4.6% ZC
Both products are broad-spectrum, foliar insecticides used across wide range of
crops. Syngenta markets these combination products under brand names Voliam Flexi® and Ampligo®. We estimate the market size of the CTPR combination products to around Rs 800 crore in India.
NATCO is the 1st company, after Syngenta, to launch above mentioned CTPR combination
products in India. It follows on the heels of indigenously manufactured CTPR formulation 18.5% SC launched by NATCO recently under brand name NATGEN. NATCO has challenged FMC for
revocation of their patents for these combination products that are marketed by Syngenta, and the case is pending before the Hon'ble High Court of Delhi. NATCO is committed to bringing high quality agrochemical products at affordable prices to farmers across India.
NATCO Launches Chlorantraniliprole (CTPR) Formulated Product NATGEN 02 September 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has launched Chlorantraniliprole (CTPR) 18.5% SC under the Brand name of NATGEN in Indian market.
NATCO estimates the current market size of CTPR containing products in India to be over INR 2000 crores.
NATCO gets CTPR launch approval from Delhi High Court 19 September 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) today received Order from Hon’ble High Court of Delhi stating that NATCO is allowed to launch Chlorantraniliprole (CTPR) and its formulations, through its non-infringing process.
NATCO is the 1st Company in India to have received its registration approval given by Central Insecticide Board & Registration Committee (CIB&RC) recorded in its Minutes of the 425th Meeting held on January 25th, 2021, for indigenous manufacture of Chlorantraniliprole (CTPR) Technical 93.00% w/w min. under Section 9(3). CTPR technical is formulated into broad-spectrum insecticides used across wide range of crops for pest management.
NATCO estimates the current market size of CTPR containing products in India to be over INR 2000 crores. The Company plans to launch its products very shortly
NATCO announces tentative approval to its ANDA for Trabectedin (generic for Yondelis®) 17 August 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces today that the U.S. Food and Drug Administration has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection (generic for Yondelis® ) for the 1mg/vial presentation.
According to industry sales data, Yondelis® generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
*All brand names and trademarks are the property of their respective owners.
NATCO records INR 918.9 Crore consolidated revenue and INR 320.4 Crore of profit, after tax, for the First Quarter, FY2022-23 09 August 2022
Hyderabad based NATCO Pharma Limited (NSE:NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 918.9 Crore for the first quarter ended on 30th June 2022, as against INR 427.3 Crore for the same period last year, reflecting a growth of 115%. The net profit for the period, on a consolidated basis, was INR 320.4 Crores as against INR 75.0 Crores same period last year.
During the quarter, export sales of Lenalidomide product to United States was a major
contributor to the revenue and profitability of the business. Pharma domestic formulations
business remained steady. On the expense side, there was a one-time cost associated with
retirement schemes during the quarter and higher than usual R&D costs for product
development.
Segmental Revenue Split (All Figures in Crore)-
| Segment |
Revenue Q1 FY23 |
Revenue, Q4 FY22 |
Revenue Q1 FY22 |
| API |
50.8 |
48.6 |
61.6 |
| Formulations, Domestic |
88.5 |
76.3 |
200.6 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
736.9 |
465.1 |
145.4 |
| Other Operating income & non-operating income |
41.7 |
20 |
19.2 |
| Crop Health Sciences (CHS) |
1 |
0.6 |
0.5 |
| TOTAL |
918.9 |
610.6 |
427.3 |
The Board of Directors has declared an interim dividend of INR 3.5 per equity share of INR 2.0 each, during the First Quarter of FY 2022-23.
Edelweiss Securities invites you to Natco Pharma Q1 FY23 Earnings call 05 August 2022
Edelweiss Securities is hosting a conference call with the management of Natco Pharma to discuss the Company’s Q1 FY23 financial results on Wednesday, August 10, 2022 at 11.00 AM IST. Mr. Rajeev Nannapaneni, Director & Chief Executive Officer and Mr. Rajesh Chebiyam, Executive Vice President – Crop Health Sciences will represent Natco Pharma on the call.
Click here for more information
NATCO Announces . Launch of First Generic Version of Nexavar® (Sorafenib) Tablets in the U.S. Market 02 June 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of the first generic version of Nexavar® (Sorafenib) Tablets in 200 mg strength today in the U.S. market. The product will be launched by NATCO’s commercial partner Viatris, a global pharmaceutical company.
Sorafenib is prescribed for treatment of unresectable Hepatocellular Carcinoma (HCC), advanced Renal Cell Carcinoma (RCC) and Differentiated Thyroid Carcinoma (DTC). For more information refer to the full prescribing information or other medical resources.
Nexavar® registered sales of USD 69.7 million for the year ending December 2021 as per industry sales data.
Nexavar ® is a registered trademark of Bayer Healthcare Pharmaceuticals Inc. All brand names and trademarks are the property of their respective owners.
NATCO Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®) 25 July 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces today that the U.S. Food and Drug Administration has granted approval to its partner Breckenridge Pharmaceutical Inc’s Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®) for the 60mg/1.5mL (40mg/mL) strength.
Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time. According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022.
NATCO records INR 2043.8 Crore consolidated revenue and INR 170.0 Crore of profit, after tax, for the year ended March 31' 2022 30 May 2022
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2043.8 Crore for the year ended on 31st March, 2022, as against INR 2155.7 Crore for the last year. The net profit for the period, on a consolidated basis, was INR 170.0 Crore, as against INR 442.4 Crore last year.
The reduction in the profit was primarily due to inventory value write-off and provision of receivables related to Covid products, with inventory value write-off of INR 232.0 Crore and provision of INR 46.0Crore towards estimated credit loss. Export business performed well during the quarter driven by Lenalidomide sales and profit.
For the fourth quarter (04) ended March 31st, 2022, t he company recorded a net revenue of INR 610.6 Crore, on a consolidated basis, as against INR 359.7 Crore during Q4, FY 2021. There was a loss for the fourth quarter period, on a consolidated basis, of INR 50.5 Crore, primarily due to inventory value write-off and provision of estimated credit losses, as against a profit of INR 53.0 Crore same quarter last year.
The company is confident of strong business growth during FY2022-23 lead by export business of Lenalidomide and growth in other business segments.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue Q4 FY22 |
Revenue, Full Year FY22 |
| API |
48.6 |
248.2 |
| Formulations, Domestic |
76.3 |
477.1 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
465.1 |
1184.1 |
| Other Operating income & non-operating income |
20 |
129.5 |
| Crop Health Sciences (CHS) |
0.6 |
4.9 |
Edelweiss Securities invites you to Natco Pharma Q4 FY22 Earnings call 25 May 2022
Edelweiss Securities is hosting a conference call with the management of Natco Pharma to discuss the Company’s Q4 FY22 financial results on Tuesday, May 31 2022 at 11.00 am, IST. Mr. Rajeev Nannapaneni, Director & Chief Executive Officer and Mr. Rajesh Chebiyam, Executive Vice President – Crop Health Sciences will represent Natco Pharma on the call.
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NATCO Announces Launch of the First Generic Version of Revlimid® (Lenalidomide capsules), in the U.S. market 07 March 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816), NATCO Pharma Limited, along with its marketing partner Arrow International Ltd (an affiliate of Teva Pharmaceutical Industries Ltd), are pleased to announce launch of the first generic version of Revlimid® (Lenalidomide capsules) in 5 mg, 10 mg, 15 mg, and 25 mg strengths in the U.S. market.
The above strengths of lenalidomide capsules are prescribed in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone (2) certain myelodysplastic syndromes and (3) mantle cell lymphoma following specific prior treatment. For more information refer to the prescribing information or other medical resources.
NATCO and Teva are launching these strengths of lenalidomide pursuant to a license of patents owned by Celgene (now part of Bristol-Myers Squibb).
NATCO records INR 590.7 Crore consolidated revenue and INR 80.4 Crore of profit, after tax, for the Third Quarter, FY2021-22 14 February 2022
Hyderabad based NATCO Pharma Limited (NSE : NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 590.7 Crore, including product licensing income, for the Third
quarter ended on 31st December, 2021, as against INR 386.0 Crore for the same period last year,
reflecting a 53% increase in revenue. The net profit for the period, on a consolidated basis, was INR
80.4 Crores as against INR 63.40 Crore same period last year, with increase of 27% in net profits.
During the quarter, there was a one-time expense aga inst product licensing income.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue in INR crores, Q3 FY22 |
| API |
61.7 |
| Formulations, Domestic |
100.3 |
| Formulations, Exports (incl. Profit Share, Licensing Inc & Foreign Subs) |
383.1 |
| Other Operating income & non-operating income |
45.3 |
| Crop Health Sciences (CHS) |
0.3 |
The Board of Directors has recommended Third interim dividend of INR 2.0 per equity share of INR
2.0 each, for FY 2021-22.
Investec India invites you to Natco Pharma Q3 FY22 Earnings call 10 February 2022
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Executive Vice President – Crop Health Sciences) will represent NATCO Pharma on the call. The call is scheduled for Tuesday, February 15th, 2022 at 11 am. It would run for an hour.
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NATCO announces License Agreement with the Medicines Patent Pool 20 January 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a non-exclusive licenses agreement with the Medicines Patent Pool (MPP), Switzerland. MPP had taken license from Merck Sharp & Dohme Corp. (MSD), USA for the same.
Natco with this license agreement can manufacture and sell Molnupiravir Capsules 200 mg. for Indian market, which will be sold under brand name MOLNUNAT ® for treatment of Covid 19 infection with Sp02>93% and who have high risk of progression of the disease including hospitalization or death.
This agreement allows Natco to expand access to Covid-19 medicines in 105 countries in generic name. Under the license, Natco can set its own price for the generic products it produces, paying a royalty on sales to MSD. MSD, Ridgeback Biotherapeutics and Emory University will not receive royalties for sales of Molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.
NATCO Pharma Limited has been awarded Corporate Governance Award 07 January 2022
NATCO Pharma Limited (the Company) pleased to inform that the Company has been awarded Corporate Governance Award for the year 2021 at the virtual event held on January 6, 2022 organised by Moneylife Foundation, a non-profit organisation registered with the Charity Commissioner of Mumbai in the year 2016. Our Company has been selected from the nominations that it had received on its own from Moneylife readers, many top investors, analysts, fund managers, bankers, academics, and researchers. The award was presented by Sri M. Damodaran, former Chairman of SEBI.
The jury for selection of Corporate Governance Award for the first time are Sri R Balakrishnan, Prof. JP Singh (from IIM Ahmedabad – Retd.), Sri Gautam Bafna, Founder and CEO of Wisdom Torch Consulting Solutions LLP and Deputy Editor Sri Yogesh Sapkale as Member-Secretary. The framework and evaluation template to judge the 35 Companies under standard parameters are Statutory compliance, board composition and functioning, communication with shareholders, shareholder-related actions, ownership structure, related-party transactions, extraordinary gestures, investor perception, etc.
NATCO completes acquisition of Dash Pharmaceuticals LLC 01 January 2022
NATCO Pharma Inc. USA, a wholly owned subsidiary of NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) (“NATCO”), has completed the acquisition of Dash Pharmaceuticals LLC (“Dash”), a New Jersey based entity. Pursuant to this, Dash will become a 100% wholly owned subsidiary of NATCO Pharma Inc. and a step-down subsidiary of NATCO. The acquisition amount paid is US$ 18 million.
Dash is a front-end pharmaceutical sales, marketing and distribution entity in the USA which is expected to have Net Sales of approximately USD 15 million for the financial year ending December 2021.
This acquisition provides NATCO with a platform to engage with its customers directly in the USA which is the largest pharmaceutical market in the world
NATCO receives approval for the drug for the treatment of Covid-19 in India 28 December 2021
Natco Pharma Limited {NSE: NATCOPHARM; BSE: 524816) has received approval for Covid 19 drug Molnupiravir Capsules 200 mg. for Indian market, which will be sold under brand name MOLNUNAT ®. Molnupiravir is the first Covid drug authorized by Drugs Controller General {India) (DCGI) for the treatment of Covid 19 infection with Sp02>93% and who have high risk of progression of the disease including hospitalization or death. This capsule was earlier approved in United Kingdom and United States of America.
MOLNUNAT will be marketed by Natco and will be priced affordably. Molnupiravir is the first Covid drug available in Indian market with a minimal dosage duration of 5 days with promising viral clearance. Phase 3 trials of Molnupiravir has shown significant reduction in hospitalization of Covid 19 patients.
NATCO proposes to acquire Dash Pharmaceuticals LLC 14 December 2021
NATCO Pharma Limited through its affiliates is proposing to enter into an agreement to acquire Dash Pharmaceuticals LLC ("Dash") subject to satisfactory completion of due diligence, execution of definitive agreements and compliance with statutory requirements. Dash is a front-end pharmaceutical sales, marketing and distribution entity based in New Jersey, USA which is expected to have approximate net sales of USD 15 million for the year ending December 2021.
This acquisition provides NATCO with a front-end to engage with its customers directly in the USA which is the largest pharmaceutical market in the world.
NATCO launches Tipanat tablets in India, for the treatment of advanced colorectal and gastric cancer 18 November 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has launched a novel fixed-dose combination of Trifluridine + Tipiracil for the first-time in India under the brand name Tipanat as a pack of 20 tablets in a bottle. Tipanat is a novel antineoplastic nucleoside analog indicated for the treatment of advanced colorectal and gastric cancer.
In India, approximately 1,25,000 new cases of the above-mentioned cancers are reported every year. Tipanat is of high importance in not only extending the survival but also in preserving the quality of life in the late lines of treatment which is currently an unmet medical need. NATCO has offered Tipanat at an affordable price.
NATCO records INR 415.2 Crore consolidated revenue and INR 65.1 Crore of profit. after tax, for the Second Quarter, FY2021-22 11 November 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 415.2 Crore for the Second quarter ended on 30th September, 2021,
as against INR 827.90 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 65.1 Crores as against INR 203.90 Crore same period last year. The decline in revenue and profits compared to last year quarter is primarily due to a one-off contribution in prior
period earnings.
The company is poised for growth during latter half of this financial year and confident of a strong rebound in business. During this quarter, Lenalidomide product in Canada and Everolimus higher strength product in USA were launched. The revenues from these products will be realized in immediate quarters. The company is well prepared for its major launch of Lenalidomide in USA during Q4 of this financial year.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue in INR crores, Q2 FY22 |
| API |
76.3 |
| Formulations, Domestic |
99.8 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
190.5 |
| Other Operating income & non-operating income |
45.1 |
| Crop Health Sciences (CHS) |
3.5 |
The Board of Directors has recommended a second interim dividend of INR 0.5 per equity share of
INR 2.0 each, for FY 2021-22
Investec invites you to the Q2 FY22 Earnings call of Natco Pharma Limited 09 November 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Executive Vice President – Crop Health Sciences & Head – Investor Relations) will represent NATCO Pharma on the call. The call is scheduled for Friday, November 12th, 2021 at 11 am. It would run for an hour.
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NATCO announces launch of its 10mg strength for Everolimus Tablets (generic for Afinitor®) in the US market 01 October 2021
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816: Announces today that its marketing partner Breckenridge Pharmaceutical, Inc., US has launched the 10mg strength of Everolimus Tablets (generic for Afinitor®) in the US market. The U.S. Food and Drug Administration previously granted final approval of this Abbreviated New Drug Application. According to industry sales data, the 10mg strength of Afinitor generated annual sales of $392 million during the twelve months ending July 2021. Breckenridge previously launched Everolimus tablets in 2.5mg, 5mg and 7.5mg strengths during the first quarter of 2021 in the US market.
*All brand names and trademarks are the property of their respective owners.
Natco Pharma (Canada) Inc. announces the launch of PrNAT-LENALIDOMIDE Capsules, the first generic alternative to Revlimid® 02 September 2021
Natco Pharma (Canada) Inc., a subsidiary of Natco Pharma Limited, announced today the launch of Pr NAT-LENALIDOMIDE Capsules, the first generic alternative to Revlimid® to be approved by Health Canada.
PrNAT-LENADLIDOMIDE is used in combination with dexamethasone for the treatment of multiple myeloma in patients who are not eligible for stem cell transplant. PrNAT-LENALIDOMIDE is also indicated for treatment of transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion of 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
“We are proud to have led the way for an accessible treatment option for multiple myeloma that may alleviate the financial burden for myeloma patients, as well as public and private payers,” said Glenn Ikeda, Ph.D., CEO of Natco Pharma (Canada) Inc. “Our team has been working diligently to improve the supply of accessible, high-quality medicines to Canadian patients. The launch of PrNAT-LENALIDOMIDE represents an important milestone in Natco’s continued efforts to expand its product portfolio and is the result of considerable Canadian investment that will bring cost savings to healthcare at a critical time.”
Sales of oncology medicines have nearly tripled over the past decade with a shift towards higher-cost drugs. Multiple myeloma, commonly referred to as myeloma, is a cancer of plasma cells and the second most common form of blood cancer. Patients with this type of cancer may have low blood cell counts and immune problems giving them a higher chance for getting infections such as pneumonia. The bones can be affected leading to bone pain and breaks (fractures).
About 7,400 Canadians are living with or are in remission from myeloma and every day, nine Canadians are diagnosed with the disease. To date there is no cure for myeloma, however several types of treatments help control the disease.
“As a self-administered capsule, lenalidomide is an important therapy for Canadian patients whose lives are critically impacted by a variety of myeloma-related events and symptoms. This treatment aims at prolonging survival and improving quality of life. The availability of NAT-LENALIDOMIDE as the first generic alternative to Revlimid® is excellent news,” commented Joe Kamel, Registered Pharmacist, at Pure Health Pharmacy in Barrie, Ontario.
r NAT-LENALIDOMIDE is available through the RevAid® risk management plan in strengths of 2.5 mg, 5mg, 10 mg, 15 mg, 20 mg and 25 mg capsules.
NATCO records INR 427.30 Crore consolidated revenue and INR 75 Crore of profit, after tax, for the first quarter ended 30th June 2021 12 August 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 427.30 Crore for the quarter ended on 30th June 2021 as against INR 582.10 crores for Q1, FY 2020. The net profit after tax for the period, on a consolidated basis, was INR 75 Crore as against INR 122.10 crores for same quarter in the last financial year.
The degrowth in sales can be partially attributed to the higher proportion of initial phase of pandemic exports to USA in Chloroquine Phosphate tablets and Oseltamivir Phosphate capsules in the revenues for the quarter ended 30th June 2020.
The pandemic continues to impact the revenues of the company but recovered compared to quarter ending March 2021.
The Company has strong product launches both in Export markets and domestic India business during the current financial year and expects to have good growth.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue in INR crores, Q1 FY22 |
| API |
61.6 |
| Formulations, Domestic |
200.6 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
145.4 |
| Other Operating income & non-operating income |
19.2 |
| Crop Health Sciences (CHS) |
0.5 |
The Board of Directors has recommended an interim dividend of INR 2.0 per equity share of INR 2.0 each, during the First Quarter of FY 2021-22.
Investec invites you to the Q1 FY22 Earnings call of Natco Pharma Limited 09 August 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, August, 12, 2021 at 6.00 PM and would run for an hour.
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NATCO transfers Lenalidomide ANDA to Arrow 04 August 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces that it has transferred the Lenalidomide Capsules ANDA (2.5mg, 5mg, 10mg, 15mg, 20mg and 25mg strengths) to Arrow
International Limited as per an earlier agreement between the parties.
This transfer of the ANDA to Arrow does not materially change any of the terms of the agreement between the parties.
Arrow International Limited (an affiliate of Teva Pharmaceutical Industries Ltd) is the marketing partner of NATCO for this product in the US market. The ANDA was approved by USFDA in May 2021 with final approval in the 5mg, 10mg, 15mg, and 25mg strengths, and tentative approval in the 2.5mg and 20mg strengths.
Legal Update 07 July 2021
Natco Pharma Limited (NSE:NATCOPHARM, BSE: 524816} states that the Hon'ble High Court of Delhi has today orally pronounced judgment in the interim injunction application filed by FMC Corporation on CTPR. The Hon'ble Court said that it has allowed the application of FMC Corporation. The full copy of the Judgment is yet to become available. Natco will review all its options after the full Judgment becomes available to it.
NATCO records INR 2155.7 Crore consolidated revenue and INR 442.4 Crore of profit, after tax, for the full year ended March 2021 17 June 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2155.7 Crore for the year ended on 31st March, 2021, as against INR 2022.4 Crore for the last year, reflecting a revenue growth of 6.6 %, year-over-year. The net
profit for the period, on a consolidated basis, was INR 442.4 Crore, as against INR 458.1 Crore last year, showing a slight decline of 3.4%.
For the fourth quarter (Q4) ended March 31st, 2021, the company recorded a net revenue of INR 359.7 Crore, on a consolidated basis, as against INR 477.2 Crore during Q4, FY20. The profit after
tax, on a consolidated basis, was recorded as INR 53.0 Crore for the quarter, as against INR 93.2 Crore same quarter last year.
In spite of significant negative impact of the pandemic on the base business, the company was able to sustain its revenue during the year. The company expects strong growth during the current year due to multiple high value product launches in the USA, rebound in domestic India
business with new products and contribution from Crop Health division.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue, Q4FY21 |
Revenue, Full Year FY21 |
| API |
70.8 |
512 |
| Formulations, Domestic |
81.8 |
410.2 |
| Formulations, Exports (incl. Profit Share &Foreign Subs) |
158.8 |
1077.1 |
| Other operating income& non-operating income |
47 |
154.3 |
| Crop Health Sciences |
1.3 |
2.1 |
Investec invites you to the Q4 FY21 Earnings call of Natco Pharma Limited 15 June 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, June, 18, 2021 at 11.00 AM and would run for an hour.
Click here for more information
NATCO receives approval for Carfilzomib Vials ANDA (generic for KYPROLIS® ) in the US market 14 June 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for
KYPROLIS®), from the U.S. Food and Drug Administration (USFDA).
The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. Based on the ANDA filing date NATCO believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch.
In the year 2019, the parties have reached a Settlement Agreement on para IV litigation related to the product with Onyx Therapeutics, Inc. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic carfilzomib products on a date that is held as confidential in the year 2027 or sooner depending on certain occurrences.
As per industry sales data, KYPROLIS® had generated annual sales of $696million during the twelve months ending December 2020 in the US. 10mg strength alone generated sales of $63million for the same period
NATCO receives USFDA approval for Lenalidomide Capsules 22 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5mg, 10mg, 15mg, and 25mg strengths, from the U.S. Food and Drug Administration (FDA), and the tentative approval of the 2.5mg and 20mg strengths.
NATCO, along with its marketing partner Arrow International Limited (a U.S. affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID®. NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
NATCO receives final approval for Everolimus tablets (generic for ZORTRESS9 ) in the US market 22 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for ZORTRESS ®),from the U.S. Food and Drug Administration (USFDA).
NATCO's partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the
product shortly.
The above strengths of Everolimus are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver Transplantation. As per industry sales data, ZORTRESS® and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.
NATCO starts Phase-III Clinical Trial of Molnupiravir capsules for Covid-19 treatment 21 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has initiated Phase-III clinical trial of Molnupiravir capsules in India. Its first patient was dosed today in Yashoda Hospitals, Hyderabad.Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response within five days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.
Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir
Capsules in mild COVID-19 patients. NATCO’s clinical trial is planned in 32 hospitals across India. A few established hospitals locally include Yashoda Hospitals,
Gleneagles Global Hospitals, KIMS Hospital in Secunderabad and Vizag, and Excel
Hospital, where the trial is being conducted
NATCO signs Voluntary Licensing Agreement with Lilly for Baricitinib for Covid-19 in India 17 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to
announce the signing of a royalty-free, non-exclusive, voluntary licensing agreement with Eli Lilly and Company, for the manufacture and commercialization of the drug Baricitinib for Covid-19 indication in India. In line with the licensing agreement, Natco has withdrawn its application filed with the Indian Patent Office, seeking Compulsory License against Lilly for Baricitinib for Covid-19 in India.
NATCO had earlier received an emergency use authorization for Baricitinib tablets, from Central Drugs Standard Control Organization (COSCO), for use in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
NATCO receives Emergency Use approval for Baricitinib tablets for Covid-19 treatment 03 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients.
Natco will be requesting a Compulsory License based on emergency use and in light
of the grave and serious public health emergency across India due to the Pandemic. The company is ready to launch the product this week, so as to make the product available to suffering patients across India
NATCO seeks Emergency approval of Molnupiravir capsules for Covid-19 treatment 26 April 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has applied to the Central Drugs Standard
Control Organization (CDSCO) in India for approval of Phase-III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 positive patients.
Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response
within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.
NATCO is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients. “Compassionate use” approval is given for investigational drugs so a patient with
an immediately life-threatening condition can gain access to the drug. The company is ready to launch the product this month if approval is given.
NATCO receives tentative approval for Ibrutinib tablets (generic for IMBRUVICA ®) ANDA in the US market 12 April 2021
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for our Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA®), from the U.S. Food and Drug Administration (USFDA).
Based on our ANDA filing date and the approval timeline, NATCO believes that we are eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form of the product
at the time of launch.
As per industry sales data, IMBRUVICA® (Tablet and Capsule dosage forms) had generated annual sales of $3.7 billion during the twelve months period ending December 2020 in the US market, of this, all the
strengths of IMBRUVICA® Tablets alone generated sales of $3.0 billion during the same period.
NATCO forays into Pheromone based technology for Integrated Pest Management 15 March 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its foray into Pheromone based mating disruption technology for Integrated Pest Management (IPM) solution to farmers in India. NATCO through its Crop Health Science (CHS) division is working with ATGC Biotech Pvt Ltd (ATGC) for the technology. ATGC is a science based innovative technology company concentrating on developing new biosafe molecules and tools to protect diverse crops from insect pests, in collaboration with US based agricultural biotech company ISCA Inc.
During Kharif 2021, NATCO plans to launch its first Green Label Pheromone product for Effective Management of Pink Bollworm (PBW) in cotton crop, under its brand NATMATE PBW. This is the first pheromone-based indigenously manufactured product for mating disruption that received approval from Central Insecticide Board (CIB). With this launch, cotton farmers will have a new and powerful tool to manage PBW.
Pink Bollworm posed a major challenge in the past few years to cotton farmers across India. The damage to quality and yield of cotton due to PBW is significant and often severely affects the livelihood of small farmers. Now, NATMATE PBW will be a tool in the hands of farmers and seed producers in developing an Insect Resistance Management (IRM) plan and preserve benefits of Bt traits in cotton as well.
NATCO receives final approval for Everolimus tablets (generic for Afinitor®) for the US market 08 March 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for Afinitor®) from the U.S. Food and Drug Administration (USFDA).
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks. The launch of 10 mg strength of the product is subject to confidential terms of a settlement and license agreement entered into with the owner of the Afinitor® brand.
The launch date of 10 mg strength of the product will be announced at a later date.
The above strengths of Everolimus are indicated in the treatment of breast cancer and a few other types of cancers. As per industry sales data, Afinitor® and its therapeutic equivalents had
generated annual sales of $712 million in USA during the twelve months ending December 2020.
*All brand names and trademarks are the property of their respective owners.
NATCO launches Brivaracetam tablets, in India, for treatment of epilepsy 26 February 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of Brivaracetam tablets under brand BRECITA in India. Brivaracetam is indicated towards treatment of epilepsy.
Brivaracetam is developed by UCB Pharma and currently marketed in India by Dr Reddy’s under brand name Briviact®. NATCO’s BRECITA tablets will be available in two strengths of 50mg and 100mg at significantly lower MRP prices of INR 25/- and INR 35/- per tablet respectively. Epilepsy patients in India is estimated to be between 5-10 million, as per GEMIND guidelines.
NATCO records INR 386.0 Crore consolidated revenue and INR 63.4 Crore of profit, after tax, for the Third Quarter, FY2020-21 11 February 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 386.0 Crore for the Third quarter ended on 31st December 2020, as against INR 513.0 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 63.40 Crore as against INR 104.4 Crore same period last year. The decline in revenue and profits was due to lower sales in domestic oncology and weak realization of profits from oseltamivir product in the USA.
Segmental Revenue Split (approx.), for Quarter 3 (All Figures in INR Crore)
| Segment |
Revenue, Q3 FY21 |
| API |
97.8 |
| Formulations, Domestic |
95.3 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
162.1 |
| Other Operating income |
5.9 |
| Other Income |
24.9 |
The Board of Directors has recommended a third interim dividend of INR 1/- per equity share of INR 2/- each.
Investec invites you to the Q3 FY21 Earnings call of Natco Pharma Limited 08 February 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, February, 12, 2021 at 11.00 AM and would run for an hour.
Click here for more information
NATCO receives approval for Chlorantraniliprole (CTPR) - 1st key product of Crop Health Sciences Division 05 February 2021
Natco Pharma Limited (NSE : NATCOPHARM ; BSE: 524816) is pleased to announce its registration approval given by Central Insecticide Board & Registration Committee (CIB&RC) recorded in its Minutes of the 425th Meeting held on 25.01.2021, for indigenous manufacture of Chlorantraniliprole (CTPR) Technical 93.00% w/ w min. under Section 9(3) of Insecticides Act, 1968. NATCO would be the 1st indigenous manufacturer of this technical product.
CTPR technical is formulated into broad-spectrum insecticides used in several crops for better pest management. NATCO hopes to bring products based on CTPR shortly that would be affordable and accessible to farmers across India.
CTPR is an active ingredient used in products commercialized by FMC under brands Coragen® & Ferterra®. The sales generated from CTPR containing products in India, inclusive of third-party marketing companies, as per declaration given by FMC was estimated to be INR 1540 crores in 2016. NATCO believes the current market size to be over INR 2000 crores. NATCO has a pending litigation against FMC for declaration of freed om to use of CTPR.
NATCO launches anti blood clot tablet Rivaroxaban in India 17 December 2020
Natco Pharma Limited {NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of
Rivaroxaban molecule, under brand RPIGAT. Rivaroxaban is an anticoagulant medication used
to treat and prevent blood clots. Rivaroxaban is currently sold by Bayer under brand name of
Xarelto®, in the lndianmarket.
After successful previous launches of DABIGAT (Dabigatran) and AP IGAT (Apixaban) by NATCO,
this latest Rivaroxaban NOAC (Novel oral anti-coagulant) is in line with our Company's mission of
affordable medicines accessible to all. NATCO has launched RPIGAT in four strengths- 20 mg, 15
mg, 10 mg and 2.5 mg. The 20 mg strength is priced at an MRP of INR 14.0 per tablet.
NATCO records INR 827.90 Crore consolidated revenue and INR 203.90 Crore of profit, after tax, for the Second Quarter, FY2020-21 12 November 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 827.90 Crore for the Second quarter ended on 30th September, 2020, as against INR 518.90 Crore for the same period last year, reflecting 59.5% growth. The net profit for the period, on a consolidated basis, was INR 203.90 Crores as against INR 117.7 Crore same period last year, showing a growth of 73.2%.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)-
| Segment |
Revenue, Q2 FY21 |
| API |
199.7 |
| Formulations, Domestic |
108.3 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
482.0 |
| Other Operating income |
10.7 |
| Other Income |
27.2 |
The Board of Directors has recommended a second interim dividend of INR 3.0 per equity share of INR 2.0 each, for FY 2020-21.
Axis Capital Limited invites you to the Q2 FY21 Earnings call of Natco Pharma Limited 06 November 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, November, 13, 2020 at 11.00 AM and would run for an hour.
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NATCO announces launch of breast cancer medicine Lapatinib Tablets in the U.S. 30 September 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Lupin Limited (Lupin), has launched Lapatinib Tablets, 250 mg, in the United States market after NATCO received the final approval for its Abbreviated New Drug Application (ANDA) from the U.S. Federal Drug Administration (USFDA). NATCO was the 1st ANDA applicant for Lapatinib Tablets, 250mg, containing a Paragraph IV certification.
Lapatinib Tablets, 250mg, is sold under Brand name TYKERB®, of Novartis Pharmaceuticals Corporation (Novartis), which is indicated primarily for the treatment of certain types of breast cancer. For the 12 months ending June, 2020, TYKERB® had sales of approximately USO 61 million in the U.S. (IQVIA MAT June 2020).
NATCO records INR 582.1 Crore consolidated revenue and INR 122.1 Crore of profit, after tax, for the First Quarter, FY2020-21 12 August 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 582.1 Crore for the first quarter ended on 30th June, 2020, as against INR 513.3 Crore for the same period last year, reflecting an increase of 13.4%. The net profit for the period, on a consolidated basis, was INR 122.1 Crores as against INR 142.8 Crore same period last year, showing a decline of about 14.5%.
Increase in revenue was driven primarily by exports formulations business. During the quarter, the company faced margins pressure on both domestic and international formulations. In spite of lower margins during the first quarter, the company is confident of its business for remaining part of the financial year based on the order book and earnings outlook. The company expects a growth of over 25% in its earnings for FY2020-21 compared to prior year.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)
| Segment |
Revenue, Q1 FY21 |
| API |
143.92 |
| Formulations, Domestic |
125.62 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
274.23 |
| Other Operating income |
18.35 |
| Other Income |
19.95 |
The Board of Directors has recommended an interim dividend of INR 1.25 per equity share of INR 2.0 each, during the First Quarter of FY2020-21.
Axis Capital Limited invites you to the Q1 FY21 Earnings call of Natco Pharma Limited 05 August 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, August 13, 2020 at 11.00 AM and would run for an hour.
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NATCO settles on Lenalidomide for Canada 10 July 2020
Natco Pharma (Canada) Inc., Canada, a subsidiary of Natco Pharma Limited has entered into a settlement agreement with Celgene (now part of Bristol-Myers Squibb) for the product Lenalidomide Capsules in Canada. The terms of the agreement are confidential as per the agreement.
NATCO records INR 2,022.4 Crore consolidated revenue and INR 458.1 Crore of profit, after tax, for the full year ended March 2020 17 June 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,022.4 Crore for the year ended on 3Pt March, 2020, as against INR 2224.7 Crore for the last year, reflecting a decline of around 9%, year-over-year. The net profit
for the period, on a consolidated basis, was INR 458.1 Crore, as against INR 642.4 Crore last year, showing a decline of about 29%.
For the fourth quarter (Q4) ended March 31, 2020, the company recorded a net revenue of INR 477.2 Crore, on a consolidated basis, as against INR 486.7 Crore during Q4, FY 2019. The profit after tax, on a consolidated basis, was recorded as INR 93.2 Crore for the quarter, as against INR 120.4 Crore same quarter last year.
The overall decline in revenue and profits, from prior year, was primarily due to continued decline in Hepatitis C product portfolio and to an extent in oncology segment due to pricing pressures.
The company also faced slowdown in business operations during the fourth quarter due to supply chain issues amidst Covid-19 concerns, which were subsequently resolved.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)
| Segment |
Revenue, Q4 FY20 |
Revenue, FY20 |
| API |
96.4 |
355.2 |
| Formulations, Domestic |
102.6 |
540.5 |
| Formulations, Exports (incl. profit share) |
200.9 |
824.9 |
| Foreign Subsidiaries |
18.5 |
108.5 |
| Other Operating income |
20.2 |
69.5 |
| Other Income |
38.6 |
123.8 |
The Board of Directors has recommended a fourth interim dividend of INR 1.00 per equity share of INR 2/- each, resulting in a total dividend payout of INR 6.75 per equity share for the year.
Axis Capital Limited invites you to the Q4 FY20 Earnings call of Natco Pharma Limited 11 June 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, June 18, 2020 at 11.00 AM and would run for an hour.
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NATCO supports Columbia University's clinical trial of chloroquine phosphate to prevent symptomatic Covid-19 infections 22 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) reiterates its commitment in supporting a clinical trial to prevent symptomatic SARS-CoV-2 infections by donating Chloroquine Phosphate (CQ) Tablets through its marketing partner in the United States, Rising Pharmaceuticals, to a study conducted by Columbia University, New York.
After NATCO's recent donation to a global clinical trial conducted by the CROWN
(COVID-19 Research Outcomes Worldwide Network) Collaborative at the Washington University School of Medicine in St. Louis it has now committed to support the Phase 2 of a clinical trial at Columbia University. The trial aims to determine the effectiveness of CQ in preventing COVID-19 infection in healthcare workers with moderate to high risk of exposure to the virus.
Researchers at Columbia University are conducting this critical study to assess CQ
as prophylaxis against COVID-19 in healthcare workers. The Phase 2 trial will enroll 350 volunteers who work in direct patient care roles at Columbia University Irving Medical Center and who have contact with patients who may have COVID-19 infection.
NATCO has been supplying CQ Tablets, a USFDA approved drug, through its marketing partner to the United States since 2011. Columbia University, a private Ivy League research university in New York City established in 1754 is renowned across the world for its expertise in conducting well designed clinical trials and NATCO is glad to work with them on this path breaking trial.
NATCO's Vizag Formulation facility receives EIR 20 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection and receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its drug formulations manufacturing facility at Visakhapatnam (Vizag) Andhra Pradesh, India, for an inspection conducted during the period from 24th March to 30th March, 2020.
NATCO's Chloroquine for International Study to prevent SARS-CoV-2 infection In Frontline Healthcare Workers 19 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has donated
Chloroquine Phosphate Tablets through its marketing partner in the United States,
Rising Pharmaceuticals, to support a global clinical trial conducted by the CROWN
Collaborative, for Protecting Essential Healthcare Workers from COVID-19 virus.
Washington University School of Medicine in St. Louis is the clinical coordinating
center for this ambitious international trial.
The group, called the COVID-19 Research Outcomes Worldwide Network (CROWN)
Collaborative, is testing whether the antimalaria drug Chloroquine can prevent
COVID-19 infection or decrease its severity in front-line health-care workers. For
this study, Chloroquine will be donated to the U.S. arm of the Chloroquine
RepurpOsing to healthWorkers for Novel CORONAvirus mitigaTION (CROWN
CORONATION) clinical trial.
The Collaborative and the trial are funded by the COV/0-19 Therapeutics
Accelerator, an initiative with contributions from an array of public and
philanthropic donors, including Bill & Melinda Gates Foundation. Conducted at
multiple sites in North America, Europe, the UK and Africa, CROWN CORONATION
will evaluate the protective potential of weekly, twice weekly or daily doses of
Chloroquine, when compared with placebo, in frontline healthcare workers at high
risk of exposure to SARS-CoV-2. The trial aims to include at least 30,000 subjects
across the frontline healthcare workers.
NATCO has been supplying Chloroquine Phosphate Tablets, a USFDA approved
drug, through its marketing partner to the United States since 2011. More recently
NATCO's alternate facility in Vizag has also been approved to supply the same drug.
Chloroquine Phosphate Tablets are indicated predominantly for the treatment of
malaria.
There is an urgent need to identify a drug to protect essential healthcare workers
and NATCO is very glad to help battle this unprecedented crisis engulfing the world.
NATCO's Vizag formulation facility receives USFDA approval 28 April 2020
Natco Pharma Limited (NSE : NATCOPHARM; BSE: 524816) is pleased to
announce final approval of its 1st supplemental abbreviated new drug
application (sANDA) product from the U.S. Food and Drug Administration
(USFDA) filed from its new drug formulations facility in JNPC SEZ, Ramky
Pharma City, Visakhapatnam (Vizag), Andhra Pradesh, India.
The sANDA, submitted as " Prior Approval Supplement," provides for NATCO's
Vizag facility as an alternate site for manufacture of the approved drug product
for the US market.
NATCO receives establishment inspection report (EIR) for Kothur's formulation facility 25 April 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection with an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the pre-approval inspection conducted at its drug formulations facility in Kothur village, Telangana, India, during the period from 2nd March to 6th March, 2020.
USFDA completes inspection of NATCO’s Kothur formulation facility 06 March 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a Pre-approval inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur village, near Hyderabad, India, which was conducted from 2nd March to 6th March, 2020.
At the end of the inspection, the facility received a single observation related to equipment qualification of a co-mill used in the process that had operating speed slightly outside the qualification range. The company believes that this is a minor observation and can be addressed within a short period of time.
The company will provide due justification and corrective action plan with in the next 15 working days to address this observation.
NATCO records INR 513.0 Crore consolidated revenue and INR 104.4 Crore of profit, after tax, for the Third Quarter, FY 2019-20 12 February 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.0 Crore for the Third quarter ended on 31st December, 2019, as against INR 580.0 Crore for the same period last year. The net profit for the period on a consolidated
basis, was INR 104.4 Crore as against INR 159.3 Crore same period last year. The company continues to face margin pressures in its Hepatitis C portfolio.
| Segment |
Revenue
(INR crore)
Q3 FY20 |
| API |
92.5 |
| Formulations, Domestic |
152.2 |
| Formulations, Exports (incl. profit share) |
187.5 |
| Foreign Subsidiaries |
34.5 |
| Other Operating income |
17.1 |
| Other Income |
30.9 |
The Board of Directors has recommended a third interim dividend of INR 3.50 per equity share of INR 2/- each.
Axis Capital Limited invites you to the Q3 FY20 Earnings call of Natco Pharma Limited 10 February 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, February 13, 2020 at 12.00 Noon and would run for an hour.
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NATCO files ANDA for Trifluridine/ Tipiracil Hydrochloride Tablets for the USA market 03 January 2020
Natco Pharma Limited (NSE:NATCOPHARM; BSE: 524816} is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Lonsurf® (Trifluridine/ Tipiracil) tablets (15mg/6.14mg and 20mg/8.19mg). NATCO believes that it is one of the first ANDA filers for the product and could be eligible for 180 days exclusivity under certain circumstances.
Lonsurf® has recorded sales of USD 150 million for the year ending December 20 18 in the US market as per IQVIA. The drug is currently indicated for certain forms of Colorectal and Gastric Cancers. Lonsurf® is a registered trademark of Taiho Oncology, INC.
Commercial Manufacturing Operations begin in NATCO's Visakhapatnam Formulation Facility 14 November 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its Finished Dosage Formulations (FDF) facility in Visakhapatnam has commenced commercial operations. The facility is a part of the Special Economic Zone (SEZ) and intended to cater primarily to the U.S. & other international markets.
Vizag facility is a key part of NATCO's capacity expansion plans for its pipeline of products and diversification into different geographies. From capability perspective, this facility will focus mostly on oral solid dosages (tablets and capsules), including a cytotoxic block for products in the oncology segment. An application with the U.S. Food and Drug Administration (USFDA) is already filed for site transfer of the first product & to trigger a regulatory audit. Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its Finished Dosage Formulations (FDF) facility in Visakhapatnam has commenced commercial operations. The facility is a part of the Special Economic Zone (SEZ) and intended to cater primarily to the U.S. & other international markets.
NATCO records INR 518.9 Crore consolidated revenue and INR 117.7 Crore of profit, after tax, for the Second Quarter, FY 2019-20 12 November 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 518.9 Crore for the Second quarter ended on 30th September, 2019, as against INR 583.50 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 117.7 Crores as against INR 181.6 Crore same
period last year. The decline in revenues and profits compared to the same period last year is primarily due to the anticipated drop in oseltamivir product sales in the USA and Hep C sales in India.
Segmental Revenue Split (approx.), for the Quarter 2, FY2019-20, as below:
| Segment |
Revenue (INR crore) Q2 FY20 |
| API |
68 |
| Formulations, Domestic |
122 |
| Formulations, Exports (incl Profit Share) |
225 |
| Foreign Subsidiaries |
27 |
| Other Operating income |
43 |
| Other Income |
34 |
The Board of Directors has recommended second interim dividend of INR 1.00 per equity share of INR 2.00 each.
NATCO's 1st key product in Crop Health Sciences for India - Chlorantraniliprole 11 November 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce a key technical product from its Crop Health Sciences (CHS) division for Chlorantraniliprole (CTPR), a broad spectrum insecticide used in several crops, and is hoping to bring formulations based on this product with affordability and accessibility to farmers across the country. NATCO is awaiting regulatory approval of the CTPR product.
CTPR is an active ingredient used in products commercialized by FMC under their brands Coragen® & Ferterra®. The sales generated from CTPR containing products in India, inclusive of third-party marketing companies, as per declaration given by FMC is estimated to be INR 1540 crores in 2016. NATCO has filed a suit for declaration of freedom to use of CTPR, at the City Civil Court, Hyderabad, in the month of September 2019. FMC has counter-sued before the Delhi High Court, in November 2019, claiming patent infringement
Edelweiss Securities invites you to the Q2 FY20 Earnings call of Natco Pharma Limited 06 November 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Wednesday, November 13, 2019 at 11.00 AM IST and would run for an hour.
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USFDA completes inspection of NATCO’s Mekaguda active pharmaceutical ingredient facility 12 August 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 5th August, 2019 to 9th August, 2019.
At the end of the inspection, the facility received six observations mostly procedural in nature. The company believes that none of observations are related to data integrity and that all the observations can be addressed within a short period of time.
Key points of the observations in Form 483 outlined below:
• Supplier & service provider agreements to be made more robust. Some procedural improvements in gowning section recommended.
• Employees engaged in the manufacturing and packaging areas require more effective training.
• Procedural improvements needed in process revalidation protocols and approval of alternate supplier sources.
• Visual stains were observed in some early stage reactors that need further diagnosis and improvement. ‘Status tags’ for certain drying process equipment were not to be found.
• Incident report not raised for software systemic error found in Karl-Fisher instrument in the QC lab.
• Procedural and handling gaps found in settling plate management in the microbiology lab.
The company will provide due justifications and corrective action plan within the next 15 working days to address the above USFDA observations.
NATCO records INR 513.3 Crore consolidated revenue and INR 142.8 Crore of profit, after tax, for the First Quarter, FY 2019-20 09 August 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.3 Crore for the first quarter ended on 30th June, 2019, as against INR 574.5 Crore for the same period last year, reflecting a decline of about 10.6%. The net profit for the period, on a consolidated basis, was INR 142.8 Crores as against INR 181.1 Crore same period last year, showing a decline of about 21%. Despite this periodic decline in profitability, the company remains confident on its outlook for the year and beyond.
However, the amount of INR 47.40 Crores (USD 6.83 million) received as upside sharing incentive from investor CX Securities is recognized as an increase in equity and not considered as income in Profit & Loss, as per applicable accounting framework.
Segmental Revenue Split (approx.), for the Quarter 1, FY2019-20, as below-
| Segment |
Revenue
(INR crore)
Q1 FY20 |
| API |
72 |
| Formulations, Domestic |
164 |
| Formulations, Exports
(incl. Profit Share) |
213 |
| Foreign subsidiaries |
28 |
| Other operating income |
16 |
| Other income |
20 |
The Board of Directors has recommended an interim dividend of INR 1.25 per equity share of INR 2.0 each, for the financial year FY2019-20.
NATCO receives establishment inspection report for Kothur facility 05 August 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection with the receipt of Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility in Kothur Village, Telangana, India, during the period May 30th – June 5th, 2019.
Edelweiss Securities invites you to the Q1 FY20 Earnings call of Natco Pharma Limited 05 August 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled on Friday, August 9, 2019 at 3.30 PM IST. It would run for an hour
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USFDA completes inspection of NATCO’s Chennai formulation facility 15 July 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful completion of regulatory inspection from the U.S. Food and Drug
Administration (FDA) for its Active Pharmaceutical Ingredient (API) facility in Chennai, India, conducted during the period July 8th – 12th, 2019. The regulatory
audit resulted in zero observations.
USFDA completes inspection of NATCO’s Kothur formulation facility 06 June 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur Village, near Hyderabad, India, which was conducted during the period 30th May, 2019 to 5th June, 2019.
At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.
Key points of the observations in Form 483 outlined below:
• Field Alert Report (FAR) was not submitted within three (3) days of receipt of information of failure of distributed batches to meet specifications. Although the out of specifications (OOS) result was invalidated, but FAR was not submitted within three (3) days of detection of OOS.
Out of trend results of a distributed batch were not extrapolated to obtain expected impurity value at the end of shelf life.
• Annual product reviews of one of the products were not approved in time.
• Visual inspection of products carried out as a part of investigation was not properly documented.
• SOP on manual interpretation of impurity peaks was made effective in November 2018, but the interpretation of impurity peaks performed prior to November 2018 were not reviewed for appropriateness and accuracy.
• Retest results performed by original analyst were considered for reporting rather than average of all retest results from the original and 2nd analyst.
• Documentation of chemical surface swabbing performed per cleaning validation on one of the products provides no description of each of individual sub swabbing samples performed for each sample location.
• Master Production and control records for one of the product does not include the operational parameters of peristaltic pumps used.
• Mechanical stirrer used in the manufacturing of one of the product does not have documented range or speed verification using a calibrated tachometer.
• Standard weights used to perform daily calibration of balances, or ferrous and non-ferrous metal test pieces used during qualification of metal detector are not traceable to a unique identification code in calibration logs.
The company will provide due justifications and corrective action plan within the next fifteen (15) working days to address the USFDA observations.
Natco files ANDA for Bosentan 32mg Tablets for the USA market 04 June 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension.
Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer®. NATCO believes that its ANDA is possibly the sole first-to-file based on the filing date. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product.
Tracleer® is indicated for the treatment of pulmonary arterial hypertension. As per Johnson & Johnson’s annual report, for the year ending 2018, Tracleer® had registered sales of approx. $268million in the US market, and the 32 mg is one strength that is indicated for pediatric patients.
NATCO settles generic Carfilzomib Injection Patent Litigation in the US market 30 May 2019
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it has reached a Settlement Agreement with Onyx Therapeutics, Inc. on patent litigation related to generic versions of 10mg, 30mg and 60mg of Kyprolis®. NATCO has partnered with Breckenridge Pharmaceutical, Inc., who will market the product in the United States.
The parties have reached a Settlement Agreement and the District Court case has been dismissed. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic carfilzomib product on a date that is held as confidential in 2027 or sooner depending on certain occurrences. The parties cannot make further comment as to the terms of the Settlement Agreement.
NATCO believes that its 10mg ANDA is sole first to file and could be eligible for 180-days marketing exclusivity for the 10mg strength under certain circumstances.
Kyprolis® reportedly had sales of USD 586 million for the year ending December 2018 in the United States.
Kyprolis® is a registered trademark of Onyx Therapeutics, Inc.
NATCO records INR 2,224.7 Crore consolidated revenue and INR 642.4 Crore of profit, after tax, for the full year ended March 2019 27 May 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,224.7 Crore for the year ended on 31st March, 2019, as against INR 2242.4 Crore for the last year, reflecting a slight decline of less than 1%, year-over-year. The net profit for the period, on a consolidated basis, was INR 642.4 Crore, as against INR 695.2 Crore last year, showing a decline of 7.6%.
For the fourth quarter (Q4) ended March 31st, 2019, the company recorded a net revenue of INR 486.7 Crore, on a consolidated basis, as against INR 787.9 Crore during Q4, FY 2018. The profit after tax, on a consolidated basis, was recorded as INR 120.4 Crore for the quarter, as against INR 299.7 Crore same quarter last year.
Although the revenue has been flat year-over-year, the marginal decline in profit was primarily due to write-off of Oseltamivir inventory by our marketing partner in the USA. The flu-season in USA was weaker than expected resulting in the write-off of this inventory valued at approximately US$ 5.5M. On the domestic business, in spite of intense price pressures, the company has seen growth in Oncology segment.
Segmental Revenue Split (approx.), for the full year, FY2018-19, as below-
| Particulars |
Amount |
|
(Rs.in crores) |
| API |
303 |
| Formulations, Domestic |
735 |
| Formulations, Exports (incl Profit Share) |
885 |
| Foreign Subsidiaries |
109 |
| Other Operating income |
63 |
| Other Income |
130 |
The Board of Directors has declared third interim dividend of INR 1.25 per equity share of INR 2/- each, resulting in a total dividend payout of INR 6.25 per equity share for the Financial Year 18-19.
Edelweiss Securities invites you to the Q4 FY19 Earnings call of Natco Pharma Limited 22 May 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled on Tuesday, May 28, 2019 at 11.00 AM IST. It would run for an hour.
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Natco’s marketing partner Alvogen receives FDA approval for Nitroglycerin Sublingual Tablets 08 May 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner Alvogen has received the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg,
and 0.6 mg. Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
Pfizer Pharmaceuticals Ltd markets this drug under its brand Nitrostat® Sublingual Tablets in the same strengths mentioned above.
As per IQVIA data, Nitroglycerin Sublingual Tablets had total annual sales of around USD 77.3 million in the US market, for the year ending 2018.
Natco & its alliance partner Lupin receive FDA approval for generic Bosentan Tablets 02 May 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Bosentan tablets in the strengths of 62.5 mg and 125 mg. Bosentan is used for the treatment of patients with pulmonary arterial hypertension.
The tablets of Natco marketing by its partner Lupin are a generic version of Actelion Pharmaceuticals Ltd’s Tracleer® tablets in the same strengths.
As stated by our partner, Lupin, as per IQVIA MAT March 2019 data, Bosentan tablets 62.5 mg and 125 mg had an annual sales of around USD 84.8 million in the US market.
NATCO and its alliance partner Lupin receive FDA approval for lmatinib Mesylate Tablets 06 March 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for lmatinib Mesylate Tablets, 100 mg (base) and 400 mg (base). These Tablets will be marketed in the USA by Natco’s marketing partner Lupin, as generic versions of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec® Tablets, 100mg and 400mg.
lmatinib Mesylate Tablet is indicated primarily for the treatment of patients with specific types of Chronic Myeloid Leukemia (CML). Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately USD 655 million in the US (IQVIA MAT December 2018).
NATCO records INR 580.0 Crore revenue and INR 159.3 Crore of Profit, after tax, for the Third Quarter, FY 2018-19 12 February 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenues of INR 580.0 Crore for the quarter ended on December 31, 2018, as against INR 573.6 Crore during the same quarter last year.
The net profit for the period, on a consolidated basis, was INR 159.3 Crore, as against INR 217.4 Crore same quarter last year. The decline in profits during the quarter compared to last year was predominantly due to margin reduction of Oseltamivir in the USA market.
Revenue Split (approx.) for Quarter 3, FY2019- API - INR 99 Cr
Formulations, Domestic - INR 164 Cr
Formulations, Exports (incl Profit Share) - INR 257 Cr
Foreign Subsidiaries - INR 25 Cr
Other Operating & Other Income - INR 35 Cr
The Board of Directors has recommended an interim dividend of INR 3.50 per equity share of INR 2/-each.
Edelweiss Securities invites you to the Q3 FY19 Earnings call of Natco Pharma Limited 05 February 2019
Mr. Rajeev Nannapaneni (Vice Chairman and CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q3 FY2019 Earnings Conference Call on Wednesday, February 13th, 2019 at 12 PM IST hosted by Edelweiss Securities.
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NATCO and Alvogen file ANDA for Ibrutinib Tablets for the USA market 31 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica® Tablets).
NATCO and its co-development & marketing partner, Alvogen Pine Brook LLC, USA, believe that the ANDA is possibly sole first-to-file based on the ANDA filing dates. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances.
In the United States Imbruvica® brand is owned and marketed by Pharmacyclics LLC and Janssen Biotech, Inc. Imbruvica® had U.S. Sales of approximately US$ 2.6 Billion for twelve months ending September, 2018, according to data from IQVIA. As per the last tracked prescription sales, almost 83% of the sales contribution has come from the above mentioned tablet dosage forms.
NATCO launches Valsartan-Sacubitril tablet in INDIA at an affordable price, under its brand VALSAC 28 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched Valsartan-Sacubitril tablet at an affordable price, under its brand VALSAC. Valsartan-Sacubitril is a combination drug used for certain types of heart failure, and works by relaxing blood vessels, making it easier for the heart to pump blood to the body.
NATCO has launched VALSAC in 50 mg & 100 mg strengths at an MRP of INR 45.0 and INR 55.0, per tablet, respectively
NATCO initiates Greenfield Facilities for Niche Agrichemical Business 25 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has initiated work on green-field manufacturing facilities for producing Niche Agrichemical products in the Nellore District of Andhra Pradesh. These facilities will manufacture both Agrichemical Technical and Formulation products.
Natco strongly believes that its pharma strength in chemistry coupled with an acumen towards selection of niche molecules would differentiate itself in the Agrichemical space as well. Natco expects the facilities in Nellore district to be commissioned by end of 2019 with a total capital expenditure of INR 100 crores.
NATCO records INR 583.40 Crores consolidated revenue and INR 181.50 Crore of profit, after tax, for the Second Quarter, FY 2018-19 05 November 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 583.40 Crore for the second quarter ended on 30th September, 2018, as against INR 432.20 Crore for the same period last year, reflecting a growth of 35%. The net profit for the period, on a consolidated basis, was INR 181.60 Crores as against INR 84.40 Crore same period last year, showing a growth of 115%.
During the quarter, the company has witnessed growth in the formulations business- both domestic and exports. The breakup of revenues has Formulations domestic Rs. 193.87 crores, Formulation exports including profit share/service income Rs. 247.81 crores, API revenues Rs. 66.81 crores, other operating / other income Rs.53.61 crores and subsidiary revenues Rs. 21.40 crores for quarter ended 30th September 2018.
Notice of Board Meeting – November 5th, 2018 29 October 2018
This is to inform you that the meeting of the Board of Directors of the Company is scheduled to be held on Monday, the 5th day of November, 2018 at 10.30 a.m. at the Registered Office of the Company to consider the following, among other things:
1. Approval of the unaudited financial results, both on standalone and consolidated basis for the quarter and half-year ended 30th September, 2018.
2. Consideration of buy-back of equity shares of the Company and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 11.15 a.m on 29th October, 2018 to 7th November, 2018 (both days inclusive). Trading window will be opened from 8th November, 2018.
CPhI Worldwide 2018 09 October 2018
The Business Development Team at CPhI worldwide 2018, held in Madrid, Spain. CPhI Worldwide, is an annual event which allows pharma companies to connect and network with their existing and potential worldwide partners.
Court Affirms Prior Decisions Finding Copaxone® 40 mg/ml Patents Invalid- a milestone for NATCO and its market ing partner Mylan 15 October 2018
NATCO Pharma Limited {NSE: NATCOPHARM; BSE: 524816) is pleased to announce that the United
States Court of Appeals for the Federal Circuit has affirmed the District of Delaware's decision that
Teva's Copaxone® 40 mg/ml dosing patents are invalid as obvious. The Federal Circuit also
affirmed today the final written decisions issued by the Patent Trial and Appeal Board (PTAB) in
three inter partes reviews filed by Natco's marketing partner, Mylan, related to the same patents.
These were the last remaining patent infringement cases Mylan was defending in the U.S. relating
to Glatiramer Acetate Injection 40mg/ml. Today's decisions are important milestones as we
continue to focus our efforts on meeting the needs of multiple sclerosis patients in the U.S. The
invalidated patents are U.S. Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776,
which are owned by Veda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals
Industries, Ltd.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in t he U.S. with brand
sales for the 20 mg/ml dose of approximately $527 million and for the 40 mg/ml dose of
approximately $2.86 billion for the 12 months ending Aug. 31, 2018, according to IQVIA.
Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial
MS diagnoses.
Dr.Reddy’s & NATCO file Doxorubicin Hydrochloride Liposome Injection in EUROPE 13 August 2018
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its codevelopment and marketing partner Dr. Reddy’s Laboratories Ltd. has filed for Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil®, for intravenous use, for the European Markets.
Janssen’s brand Doxil® is predominantly used for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma. The Doxil® brand, 2mg/ml, had sales of approximately US$130.5 Million, in Europe, for the 12 months ending December 31, 2017, according to Quintiles IMS.
NATCO records INR 574.5 Crores consolidated revenue and INR 181.1 Crore of profit, after tax, for the First Quarter, FY2018-19 08 August 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 574.5 Crore for the first quarter ended on 30th June, 2018, as against INR 448.7 Crore for the same period last year, reflecting a growth of 28 %. The net profit for the period, on a consolidated basis, was INR 181.1 Crores as against INR 93.7 Crore same period last year, showing a growth of 93 %.
The Board of Directors approved an Interim Dividend of Rs.1.50 (75%) per equity share of Rs.2/each.
Click here for the Quarter 1 results.
Edelweiss Securities invites you to the Q1 FY19 Earnings call of Natco Pharma Limited 01 August 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q1 FY 2019 Earnings Conference Call on Thursday, August 9th, 2018 at 11:00 AM IST hosted by Edelweiss Securities.
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Notice of Board Meeting – August 8th, 2018 28 July 2018
A meeting of the Board of Directors of the Company is scheduled to be held on Wednesday, the 8th day of August 2018 at 11.00 a.m. at the Registered Office of the Company to consider, among other things, the following items of businesses and related matters:
1. Unaudited financial results for the quarter ended 30th June, 2018 along with the Limited Review Report thereon.
2. To Consider Interim Dividend, if any, for the year 2018-19.
3. Convening of 35th Annual General Meeting to be held for the financial year 2017-18.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 30th July 2018 to 10th August 2018 (both days inclusive). Trading window will be opened from 11th August 2018.
NATCO launches fixed dose combination of Sofosbuvir-Daclatasvir drug for Hepatitis C treatment in INDIA 02 July 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the first company in India to launch under its brand Hepcinat Plus, the generic fixed dose combination of Sofosbuvir 400 mg and Daclatasvir 60mg Tablet, for the treatment of patients with chronic hepatitis C virus (HCV) infection.
Natco has launched Hepcinat Plus at an MRP of INR 17,500/-, for a bottle of 28 tablets.
NATCO launches generic Posaconazole Injection- 1st time available in INDIA 08 June 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of Posaconazole Injection, 300 mg/16.7ml, under its brand POSANAT. This is the first time an injection version of this drug available in India. POSANAT will be available in 18.0 mg/ml strength, a formulation for intravenous (IV) use. Posaconazole Injection is sold in the USA market by Merck under its brand name of NOXAFIL ®.
Posaconazole injection is an antifungal agent & used in patients who are at high risk of developing infections due to being severely immunocompromised, such as associated with stem cell transplant or from chemotherapy.
NATCO records INR 2,242 Crore consolidated revenue and INR 695 Crore of profit, after tax, for the full year ended March 2018 23 May 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,242.4 Crore for the year ended on 31st March, 2018, as against INR 2078.9 Crore for the last year, reflecting an year-over-year growth of 7 .87%. The net profit for the period, on a consolidated basis, was INR 695.2 Crore, as against INR 484.9 Crore last year, showing a growth of 43.37%.
For the fourth quarter (Q4) ended March 31st, 2018, the company recorded a net revenue of INR 787 .9 Crore, on a consolidated basis, as against INR 577.2 Crore during Q4, FY 2017, posting an increase of 36.50%. The profit after tax, on a consolidated basis, was recorded as INR 299.7 Crore for the quarter, as against INR 176.4 Crore same quarter last year, showing a growth of 69.90%.
The growth in revenue and profit during the year was driven primarily by formulations business in the USA that included niche generic product launches of Glatiramer Acetate, Liposomal Doxorubicin and Lanthanum Carbonate. Additionally, generic Oseltamivir sales in the USA was a strong contributor for the company in spite of competition. The domestic oncology formulations business continued to be strong during the year.
Click here for the full FY18 results.
Edelweiss Securities invites you to the Q4 FY18 Earnings call of Natco Pharma Limited 21 May 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q4 FY2018 Earnings Conference Call on Thursday, May 24th, 2018 at 11:00 AM IST hosted by Edelweiss Securities.
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Notice of Board Meeting – May 23rd, 2018 16 May 2018
A meeting of the Board of Directors of the Company is scheduled to be held on Wednesday, the 23rd day of May, 2018 at 11.00 a.m. at the Registered Office of the Company to consider among other things, to approve the Audited Financial Results for the quarter and year ended 31st March, 2018 and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 16th May, 2018 to 25th May, 2018 (both days inclusive). Trading window will be opened on 28th May, 2018.
NATCO launches 1st generic version of Oral tablets for Multiple Sclerosis in INDIA 04 April 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the first company in India to launch a generic version of Teriflunomide, for the treatment of Relapsing and Remitting forms of Multiple Sclerosis (RRMS), under its brand DENOPSY. This is the first oral medicine for RRMS being offered in India at two different strengths- 14 mg & 7 mg tablets. Teriflunomide is sold by Sanofi-Genzyme under brand name of AUBAGIO®, in the USA market.
DENOPSY is priced attractively & much lower than other alternate options in India. As per WHO 2013 estimates, the number of patients suffering from Multiple Sclerosis in India is 5-20 per 1 lakh population.
NATCO announces USFDA filing for Sofosbuvir tablets, 400 mg 01 March 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that it has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the U.S. Federal Drug Administration (USFDA). Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi®.
Natco believes that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
For the 12 months ending Dec. 31, 2017, SOVALDI® had U.S. sales of approximately $130 million as per Gilead Sciences Inc. unaudited results released for the year ending 31st December, 2017.
USFDA completes inspection of Natco's Mekaguda API facility with zero observations 17 February 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful completion of regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 12th February, 2018 to 16th February, 2018. The regulatory audit resulted in zero observations (no form 483 issued).
NATCO records INR 573.6 Crore revenue and INR 217.4 Crore of Profit, after tax, for the Third Quarter, FY 2017-18 06 February 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenues of INR 573.6 Crore for the quarter ended on 31st December, 2017, as against INR 685.1 Crore during the same quarter last year. The decline in revenue compared to last year’s quarter was predominantly due to large stocking quantities of generic oseltamivir during last year’s period.
The company is very pleased to show strong earnings during the quarter, in spite of loss of exclusivity for generic oseltamivir in the USA market. We successfully launched several new products in the USA market recently, that includes generic versions of glatiramer acetate, oseltamivir suspension, liposomal doxurubicin and lanthanum carbonate, and continue to believe in strong growth in ensuing quarters. The net profit for the period, on a consolidated basis, was INR 217.4 Crore, as against INR 194.9 Crore same quarter last year, showing a growth of 11.5%.
Edelweiss Securities invites you to the Q3 FY18 Earnings call of Natco Pharma Limited 31 January 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q3 FY2018 Earnings Conference Call on Wednesday, February 7th, 2018 at 9.30 AM IST hosted by Edelweiss Securities.
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Notice of Board Meeting - February 6th, 2018 29 January 2018
A meeting of the Board of Directors of the Company is scheduled to be held on February 06, 2018, inter alia, to consider the following items of business:
1. The unaudited financial Results for the quarter and nine months ended December 31, 2017 (Q3) and related matters.
2. To consider Second Interim Dividend, if any, for the financial year 2017-18 and related matters etc.
Further, pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from January 29, 2018 to February 08, 2018 (both days inclusive). Trading window will be opened from February 09, 2018.
