On February 3, 2022 Pharma major Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter ending December 31, 2021 (Press release, Lupin, FEB 3, 2022, View Source [SID1234607679]). These unaudited results were taken on record by the Board of Directors at a meeting held today.

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Financial Highlights – Consolidated IND-AS

* Excluding one-time expenses of INR 1932 mn Q3 FY22 EBIDTA was INR 5971 mn and PBT was INR 3603 mn

** Adjusted for Impairment & Business Compensation Expenses in Q2 FY2022

Income Statement highlights – Q3 FY2022

Gross Profit was INR 23,929 mn compared to INR 23,769 mn in Q2 FY2022, with margin of 58.5%
Personnel cost was 18.2% of sales at INR 7,438 mn compared to INR 7,586 mn in Q2 FY2022
Manufacturing and other expenses were 33.1% of sales at INR 13,518 mn compared to INR 11,425 mn in Q2 FY2022
The financial results include one-time expenses2 of INR 1932 mn, excluding which the EBIDTA (before Fx and Other income) was 13.7% of sales
Investment in R&D for the quarter was INR 3,546 mn (8.7% of sales)
Balance Sheet highlights

Operating working capital was INR 65,680 mn as on December 31, 2021
Capital Expenditure for the quarter was INR 2,787 mn and INR 5,295 mn for 9M FY2022
Net Debt as on December 31, 2021 stands at INR 22,448 mn
Net Debt-Equity for the company as on December 31, 2021 stands at 0.18
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said, "We are on the path of sustained growth across markets. Our inhalation portfolio continues to build share in the U.S. and helped register double-digit growth sequentially, despite pricing and demand challenges on seasonal products. The inflationary environment has impacted margins, but we remain focussed on margin and EBIDTA improvement as we deliver on key product launches, cost optimization and improving efficiencies, especially by H2 FY23"

Consolidated Financial Results Q3 FY2022

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63.6% of sales in Q3 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 27.5% of sales in Q3 FY2021.
Other expenses include the impact of one-time expenses of INR 1932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.
In Q2 FY2022 we had created provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions. The amounts due to the two plantiffs group was settled in Q3.
Q2 FY2022 includes impairment Expense of INR 7,077 mn for impairment of Solosec IP.
The current tax is computed basis the concept of likely Effective Tax Rate for the year. The one-time items in Q2 create an impact on the overall profitability for first 9M, which is negative. Hence basis average ETR concept as per standards, we see a credit in tax line.
Consolidated Financial Results 9M FY2022

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63% of sales in 9M FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 27.9% of sales in 9M FY2021.
Other expenses include the impact of one-time expenses of INR 1932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.
In Q2 FY2022 we had created provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions. The amounts due to the two plantiffs group was settled in Q3.
Q2 FY2022 includes impairment Expense of INR 7,077 mn for impairment of Solosec IP.
The current tax is computed basis the concept of likely Effective Tax Rate for the year. The one-time items in Q2 create an impact on the overall profitability for first 9M, which is negative. Hence basis average ETR concept as per standards, we see a credit in tax line.

Operational Highlights

North America

North America sales for Q3 FY2022 were INR 15,775 mn, up 10.4% compared to INR 14,291 mn in Q2 FY2022, up 9.4% as compared to INR 14,424 mn in Q3 FY2021; accounting for 39% of Lupin’s global sales.

Q3 FY2022 sales were USD 202 mn compared to USD 184 mn in Q2 FY2022 and USD 188 mn in Q3 FY2021.

The Company filed 3 ANDAs in the quarter, received 3 ANDA approvals from the U.S. FDA, and launched 2 products in the quarter in the U.S. market. The Company now has 167 products in the U.S. generics market.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and U.S. total market by prescriptions (IQVIA MAT November 2021). Lupin is the market leader in 58 products in the U.S. generics market and amongst the Top 3 in 119 of its marketed products (IQVIA September 2021).

India

India formulation sales for Q3 FY2022 were INR 14,733 mn, down 4.5% as compared to INR 15,435 mn in Q2 FY2022, up 7.8% as compared to INR 13,669 mn in Q3 FY2021; accounting for 36% of Lupin’s global sales.

India Region Formulations sales grew by 11.9% in the quarter as compared to Q3 FY2021. The company launched 1 brand in the Respiratory segment and 2 brands in the Cardiac segment in the quarter.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2021).

Growth Markets (LATAM and APAC)

Growth Markets registered sales of INR 3,390 mn for Q3 FY2022, down 2.9% compared to INR 3,490 mn in Q2 FY2022, up 2.3% as compared to INR 3,314 mn in Q3 FY2021; accounting for 8% of Lupin’s global sales.

Brazil sales were BRL 49 mn for Q3 FY2022 compared to BRL 48 mn for Q2 FY2022 and BRL 66 mn for Q3 FY2021.

Mexico sales were MXN 195 mn for Q3 FY2022 compared to MXN 172 mn for Q2 FY2022 and MXN 188 mn for Q3 FY2021.

Philippines sales were PHP 401 mn for Q3 FY2022 compared to PHP 643 mn for Q2 FY2022 and PHP 367 mn for Q3 FY2021.

Australia sales were AUD 17.8 mn for Q3 FY2022 compared to AUD 18.3 mn for Q2 FY2022 and AUD 15.7 mn for Q3 FY2021.

Europe, Middle-East and Africa (EMEA)

EMEA sales for Q3 FY2022 were INR 3,422 mn, down 1.8% compared to INR 3,484 mn in Q2 FY2022, up 4.6% compared to INR 3,272 mn in Q23 FY2021; accounting for 8% of Lupin’s global sales.

South Africa sales for Q3 FY2022 were ZAR 319 mn, compared to ZAR 357 mn in Q2 FY2022 and ZAR 323 mn in Q3 FY2021. Lupin is the 6th largest player in South Africa in the total generics market (IQVIA November 2021).

Germany sales for Q3 FY2022 were EUR 8.8 mn, compared to EUR 7.9 mn in Q2 FY2022 and EUR 8.1 mn in Q3 FY2021.

Global API

Global API sales for Q3 FY2022 were INR 2,564 mn, down 4.3% compared to INR 2,678 mn in Q2 FY2022, down 25.4% as compared to INR 3,438 mn in Q3 FY2021; accounting for 6% of Lupin’s global sales.

Research and Development

Investment in R&D amounted to INR 3,546 mn (8.7% of sales) for Q3 FY2022 as compared to INR 3,300 mn (8.2% of sales) for Q2 FY2022.

Lupin received approval for 3 ANDAs from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 447 as of December 31, 2021, with the company having received 295 approvals to date.

The Company now has 50 First-to-File (FTF) filings including 20 exclusive FTF opportunities. Cumulative U.S. DMF filings stand at 196 as of December 31, 2021.

On February 3, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)- based DNA manufacturing and nucleic acid-based technologies, reported that it will report fiscal 2022 first quarter financial results after market close on Thursday, February 10, 2022 (Press release, Applied DNA Sciences, FEB 3, 2022, View Source [SID1234607678]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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Conference Call and Webcast Information – Live

Date: Thursday, February 10, 2022, at 4:30 p.m. Eastern Time
Dial in: 844-887-9402; 412-317-6798 (international)
Hosts: Dr. James A. Hayward, chairman, president, and CEO; Beth Jantzen, chief financial officer
Webcast: View Source

Conference Call and Webcast Information – Replay

A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Dial in: 877-344-7529; 412-317-0088 (international); Access Code: 2723913
Webcast: View Source
Availability: Telephonic replay: until Thursday, February 17, 2022; webcast replay: 1 year

On February 3, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported the publication of a peer-reviewed article titled, "A Small Molecule–Drug Conjugate (SMDC) Consisting of a Modified Camptothecin Payload Linked to an αVß3 Binder for the Treatment of Multiple Cancer Types" in the special issue "The Role of Tumor Microenvironment in Solid Tumors: The New Frontier of Cancer Research" of the journal Cancers (Press release, Vincerx Pharma, FEB 3, 2022, View Source [SID1234607677]). The preclinical data in the paper highlight the potential of VIP236, a small molecule-drug conjugate (SMDC), to directly target cancer cells, while reducing the harmful effects of chemotherapy to normal tissue.

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"These preclinical data provide compelling proof-of-concept that our novel SMDC, VIP236, can direct a potent cancer chemotherapy drug to tumors while sparing healthy tissues," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "We have a diverse, modular platform of linkers and payloads that can be conjugated with typical antibodies or small molecules, creating the potential for novel drugs with greater efficacy and lower toxicities than current antibody-drug conjugates; VIP236 is an example of the strength of this platform."

VIP236 tumor homing is guided by an αVß3 integrin ligand, which targets mechanisms that drive aggressive and invasive cancers. The published results provide preclinical validation of this targeting strategy and demonstrate how this approach can deliver 40 times more drug to the cancer than the surrounding tissues or normal organs. VIP236 is further activated by another component prevalent in the tumor microenvironment of invasive cancers, neutrophil elastase, which cleaves the linker, releasing a potent payload directly in the tumor microenvironment. The payload is a differentiated camptothecin (CPT) optimized to be more cell permeable and to overcome drug resistance observed with traditional CPTs.

Dr. Hamdy continued, "Our promising in vivo mouse data across various tumor types highlight the potential of our rationally designed SMDC to transform the treatment paradigm for advanced solid tumors. We look forward to advancing VIP236 into the clinic in the second half of 2022."

Key Article Highlights Include:

The αVß3 integrin targeting strategy in VIP236 increases tumor homing by 42-fold as measured by a fluorescent dye conjugated to the integrin targeting moiety and demonstrated in a human renal cell carcinoma (786-O) xenografted mouse model.
The cytotoxic payload of VIP236, VIP126, is an optimized CPT which shows improvement in permeability, efflux ratio and cytotoxicity in drug transporter overexpressing cancer cells compared with SN38, a clinically validated CPT. Unlike SN38, VIP126 is a very poor substrate for P-gp- or BCRP-mediated efflux transport, which translated into greater efficacy.
VIP236 in vitro cytotoxic activity against tumor cell lines is neutrophil elastase (NE) dependent.
Neutrophil elastase, prevalent in the tumor microenvironment, cleaves the linker, to release the anticancer payload within the tumor.
VIP236 results in a ten-fold higher tumor-to-plasma ratio of the payload, VIP126, when compared to direct administration of VIP126 in vivo, highlighting a potential therapeutic advantage of the conjugate delivery system.
Compared with commonly used chemotherapeutics, VIP236 shows very effective tumor targeting, better tumor regression, and better tolerability in mouse models of triple negative breast cancer, small cell lung cancer and colorectal cancer.

On February 3, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will be virtually participating in the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference (Press release, Akoya Biosciences, FEB 3, 2022, View Source [SID1234607676]).

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Brian McKelligon, CEO, and Joe Driscoll, CFO, are scheduled to present on Tuesday, February 15th, 2022 at 1 p.m. ET.

BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

On February 3, 2022 Amgen (NASDAQ:AMGN) and Plexium, Inc. (Plexium) reported an exclusive, worldwide, multi-year research collaboration and license agreement to identify novel targeted protein degradation therapeutics toward historically challenging drug targets (Press release, Plexium, FEB 3, 2022, View Source [SID1234607675]). The multi-year collaboration supports the discovery of novel molecular glue therapeutics leveraging insights from Amgen’s expertise in developing multispecific molecules.

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Under the terms of the agreement, the collaboration will initially focus on two programs with Amgen holding options to add additional programs. Plexium is eligible to receive over $500 million in success-based target access, pre-clinical, clinical, regulatory and commercial milestones, as well as tiered single-digit royalty payments, if all options are exercised. Amgen has a commercial license to each program that advances to a predefined preclinical stage of development and will be responsible for global development and commercialization.

"We are on the cusp of a new era of drug discovery where medicines could function very differently than conventional ones do today," said Ray Deshaies, Ph.D., senior vice president of Global Research at Amgen. "Collaborating with Plexium and leveraging their innovative technology to identify molecular glue degraders can help tackle some of the most challenging protein targets to address serious disease."

The partnership will focus on expanding targeted protein degradation opportunities through discovery of previously unrecognized molecular glues or monovalent degraders. These molecules work through a concept of induced proximity that take advantage of the normal biology of a cell to bring two proteins together to drive protein degradation. This collaboration incorporates Plexium’s comprehensive targeted protein degradation platform, powered by a proprietary high-throughput cell-based screening technology that enables the discovery of novel molecular glue therapies.

"Amgen is a globally recognized pharmaceutical company that shares our commitment to pushing the boundaries of modern drug discovery and we’re thrilled to announce our collaboration today," said Percival Barretto-Ko, president and chief executive officer at Plexium. "This partnership leverages and expands our drug discovery capabilities and will further demonstrate the power of our platform to unlock the potential of protein degradation. We look forward to working with Amgen to accelerate the discovery of the next generation of targeted protein degraders to improves patients’ lives around the globe."