Earnings Release – Q4 FY22

On May 19 , 2022: Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the fourth quarter and full year ended March 31, 2022 (Press release, Dr Reddy’s, MAY 19, 2022, View Source [SID1234614845]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS). Commenting on the results, Co-Chairman & MD, G V Prasad said: "We delivered healthy growth in revenue, though the profits were impacted by impairment charges.

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In spite of multiple external challenges, our core businesses performed well driven by an increase in market share, some strong launches and productivity improvement. We will continue to focus on growing our core businesses, invest in future growth drivers, and work towards greater integration of Sustainability in our businesses." Revenue Analysis [Q4 and full year FY22] Global Generics (GG)  GG segment at Rs. 179.2 billion higher by 16% over FY21. This growth was driven by good performance across all our markets with strong growth in Emerging markets and India.

 Q4 revenue at Rs. 46.1 billion, YoY growth of 19% and QoQ growth of 4%. The YoY & QoQ growth was driven by growth across all our markets, however the QoQ growth was partially impacted due to a decline in revenues in India. North America  Revenues from North America Generics for the year at Rs. 74.9 billion, YoY growth of 6%. The growth was contributed by new launches and scale up of existing products, which was partially offset by price erosion.  Revenues for Q4 at Rs. 20.0 billion, YoY growth of 14% and QoQ growth of 7%. The YoY and QoQ growth were primarily on account of new product launches and volume traction in some of our products, partly offset by price erosion.

 During this quarter, we launched 3 new products – Vasopressin Injection, Nicotine Lozenges Cherry Flavour (OTC) and Clobetasol Shampoo in Canada and for full year we have launched 17 products.  During the year, we filed 7 new Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (USFDA). As of 31st March 2022, cumulatively 90 generic filings are pending for approval with the USFDA (87 ANDAs and 3 NDAs under 505(b)(2) route). Out of the pending 87 ANDAs, 44 are Para IVs, and we believe 24 have ‘First to File’ status. Europe  Revenues from Europe for the year at Rs. 16.6 billion. YoY growth of 8%, primarily on account of volume traction in base business and new product launches, which was partially offset by price erosion in some of our products.  Revenues for Q4 at Rs. 4.4 billion, YoY growth of 12% and QoQ growth of 10%. YoY and QoQ growth was primarily on account of new product launches, partly offset by price erosion in the base business. India  Revenues from India for the year at Rs. 42 billion. Year-on-year growth of 26% was primarily attributable to an increase in both sales volume and price of our existing products, along with additional revenues from the launch of new products.

The growth was also aided by covid product sales. During FY2022, we launched 20 new brands in India, including Sputnik-V vaccine for Covid-19.  Revenues for Q4 at Rs. 9.7 billion, YoY growth of 15% and QoQ decline of 6%. YoY growth primarily driven by volume traction in the base business, favorable price variance, new product launches, and non-core brand divestments while QoQ decline was majorly due to decline in volumes of some of our products.Emerging Markets  Revenues from Emerging Markets for the year at Rs. 45.7 billion, growth of 30% YoY.-Revenues from Russia for the year at Rs. 20.9 billion, YoY growth of 32%. This growth was driven by improved base business performance, launch of new products during the year and divestment of a few non-core brands.-Revenues from other CIS countries and Romania for the year at Rs. 8.3 billion, YoY growth of 11%. Growth was on account of new product launches, partly offset by lower volumes.-Revenues from Rest of World (RoW) territories for the year at Rs. 16.5 billion, YoY growth of 40%.

Growth primarily on account of new launches, volume traction in key products and sale of Covid products, partially impacted by adverse price variance in certain markets.  Revenues for the quarter are Rs. 12 billion, YoY growth of 36%, QoQ growth of 4%.-Revenues for Russia for Q4 at Rs. 6.9 billion, YoY growth of 70%, QoQ growth of 45%. The increase is majorly attributable to traction in volume of base business and income from divestment of a few non-core brands. However, the QoQ growth was partly impacted by adverse forex rates.-Revenues from other CIS countries and Romania for the quarter are Rs. 2.3 billion, YoY growth of 20%, QoQ decline of 4%. YoY growth was primarily due to launch of new products and price benefits in some of our markets. The QoQ decline was on account of lower volume traction in some of our markets and adverse forex rates.-Revenues from Rest of World (RoW) territories for Q4 are Rs. 2.9 billion, YoY decline of 1% and QoQ decline of 35%. The QoQ decline is primarily due to higher base of previous quarter which includes sale of covid related products, lower volumes in some of our products and adverse price variance in some of our markets, which was offset partially by new product launches. Pharmaceutical Services and Active Ingredients (PSAI) 

Revenues from PSAI at Rs. 30.7 billion. YoY decline of 4%. The decline was majorly on account of price erosion in some of our products.  Revenues for Q4 at Rs. 7.6 billion, YoY decline of 5% and QoQ growth of 4%. YoY decline was primarily due to lower volumes and price erosion while the QoQ growth was driven by new product sales.  During the year, we have filed 10 DMFs in the US, of which 3 DMFs were filed in Q4FY22. Proprietary Products (PP) & Others  Revenues from PP & others for the year at Rs. 4.5 billion, YoY growth of 34%. The growth is attributable to recognition of a license fee associated with the sale of our U.S. and Canada territory rights for ELYXYB (celecoxib oral solution) 25 mg/ml, to BioDelivery Sciences International, Inc during Q2 FY22.

 Revenues for Q4 at Rs. 693 million.Income Statement Highlights:  Gross profit margin for the year at 53.1%, a decrease of ~120 bps over previous year. The decrease was driven by pricing pressure in the North America & Europe, lower export benefits, and an increase in the inventory provisions. This was partially offset by productivity benefits. Gross profit margin for GG and PSAI business segments are at 57.6% and 22.2% respectively. Gross profit margin for the Q4 at 52.9% (GG: 58.2%, PSAI: 18.4%). Gross margin declined by ~80 bps YoY and by ~90 bps QoQ. The decline was primarily due to price erosion, an increase in the inventory provisions, which was partly offset by income from divestment of non-core brands.  Selling, general & administrative (SG&A) expenses for FY22 at Rs. 62.1 billion, an increase of 14% on a YoY basis. This increase was primarily due to annual increments, investments in brands and digitalization, and royalty paid on sales. SG&A expenses for Q4 at Rs. 15.7 billion, YoY increase of 9% and QoQ increase of 2%. The increase is mainly due to provision made of Rs. 1.0 billion pertaining to litigation with Texas state, US. SG&A as a % to sales for the full year remained largely in line with FY21.  Impairment charge at Rs. 7.6 billion in FY22. This is majorly due to product impairment of PPC-06 (Tepilamide Fumarate Extended Release Tablets) of Rs. 4.3 billion on account of its decrease in market potential and impairment of Shreveport plant assets and Goodwill of Rs. 3.1 billion which were taken considering the triggers which occurred during the year.  Research & development (R&D) expenses in FY22 at Rs. 17.5 billion. As % to Revenues – FY22: 8.2% | FY21: 8.7%. R&D expenses for Q4 at Rs. 4.3 billion, as % to revenues stood at 8.0%. Our focus continues on building a global pipeline of new products across our markets.

 Other operating income for the year at Rs. 2.8 billion compared to Rs. 1 billion in FY21. The increase was on account of recognition of income towards sale of our rights relating to anti-cancer agent E7777 (denileukin diftitox) to Citius Pharmaceuticals in Q2 FY22. Other operating income in Q4 is Rs. 0.3 bn.  Net Finance income for the year at Rs. 2.1 billion compared to Rs. 1.7 billion in FY21. The increase is primarily on account of higher foreign exchange gain in current year as compared to FY21. Net finance income in Q4 is Rs. 0.9 billion.  Profit before Tax for the year at Rs. 32.3 billion, growth of 22%. Profit before Tax for Q4 is Rs. 2.5 bn.  Profit after Tax for the year at Rs. 23.6 billion and for Q4 at Rs. 0.9 billion. The effective tax rate for the year has been 27.0% as compared to 34.7% in FY21 and that for the quarter has been at 64.8% as compared to 41.2% in Q4 FY21. The ETR was higher on account of lower Profit before Tax, due to the impairment charge taken.  Diluted earnings per share for the year is Rs. 141.7. Diluted earnings per share for Q4 is Rs. 5.3.

Other Highlights:  EBITDA for FY22 at Rs. 51.4 billion and the EBITDA margin is 24.0%. EBITDA for Q4 FY22 is at 13.0 billion and the EBITDA margin in 23.9%.  Capital expenditure for FY22 is at Rs. 14.7 billion. Capital expenditure for Q4 FY22 is at Rs. 3.7 billion.  Free cash-flow for FY22 is at Rs. 11.6 billion and for Q4 it is at Rs. 4.8 billion.  Net cash surplus for the company is at Rs. 15.5 billion as on March 31, 2022. Consequently, net debt to equity ratio is (0.08).  The Board has recommended payment of a dividend of Rs. 30/-per equity share of face value Rs. 5/-each (600% of face value) for the year ended March 31, 2022 subject to approval of members.

Earnings Call Details (05:30 pm IST, 08:00 am EDT, May 19, 2022) The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

Evotec and Almirall enter into a multi-target alliance in medical dermatology

On May 19, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Almirall S.A. (ALM), a global biopharmaceutical company focused on skin health, reported a multi-target alliance in Medical Dermatology (Press release, Evotec, MAY 19 , 2022, View Source [SID1234614843]). The companies aim to discover and develop novel therapeutics for severe skin diseases, including immune-mediated inflammatory conditions such as atopic dermatitis and non-melanoma skin cancer such as basal cell carcinoma.

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The alliance will leverage Evotec’s fully integrated multimodality platform and combine it with Almirall’s leading expertise in Medical Dermatology. Both partners will contribute drug targets in the research process. Leveraging the Company’s end-to-end integrated, AI/ML-driven EVOiR&D platform, Evotec will be responsible for drug discovery and pre-clinical development. Almirall will lead the clinical development and marketing.

Under the agreement, Evotec receives an undisclosed upfront payment, research payments, as well as success-based milestones of potentially up to € 230 m per programme and royalties on net sales in the high single-digit percentage range.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are very happy to enter this collaboration with Almirall, one of the leaders in the field of Medical Dermatology. The collaboration has the potential to deliver superior first-in-class therapeutic options for many patients suffering from severe skin diseases such as atopic dermatitis or basal cell carcinoma. We are looking forward to leveraging the complementary expertise of Evotec and Almirall in order to develop promising new drug candidates."

Dr Karl Ziegelbauer, Chief Scientific Officer of Almirall, stated: "We are very excited about the strategic alliance with Evotec and believe that combining Almirall’s experience and know-how in Medical Dermatology with Evotec’s integrated drug discovery and preclinical development small molecule platform will enable us to deliver novel solutions for patients suffering from auto-immune skin diseases or common forms of skin cancer."

METiS joins the Roche Accelerator

On May 18, 2022 METiS reported officially joining the Roche Accelerator with the goal to tap into Roche’s global scientific expertise, laboratory facilities and foster collaboration discussions on formulation development and optimization with Roche Innovation Center Shanghai (Press release, METiS Therapeutics, MAY 18, 2022, View Source [SID1234648429]).

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"We are excited to become a member of the Roche Accelerator and to establish a closer connection with a global leader in healthcare like Roche," said Chris Lai, co-founder and CEO of METiS. "We look forward to testing METiS’ proprietary AiTEM platform together and exploring deeper collaboration opportunities to bring optimized therapeutics to patients around the world."

Traditionally, new drug molecules face many obstacles in drug development, including inadequate pharmacokinetic properties due to poor permeability and / or low solubility, which significantly affect their druggability. Tissue-specific delivery of nucleic acid-based medicines can be even more challenging, and it is critical to understand how drug molecular structures interact with excipients and nanomaterials, and the impact of physiological microenvironments on the physical and chemical properties.

The METiS platform, AiTEM, combines cutting-edge AI data-driven algorithms, mechanism-driven quantum mechanics and molecular dynamics simulations, to calculate Active Pharmaceutical Ingredient (API) properties, elucidate APItarget and API-excipient interactions, and predict chemical, physical and pharmacokinetic properties of small molecule and nucleic acid therapeutics in specific microenvironments, and screen for optimal formulations from tens of thousands of data points. This enables rapid and efficient candidate selection and formulation design, programmable nucleic acid drug development and its delivery design.

Dr. Qiusong Tang, Head of Roche Accelerator, said: "We have been witnessing digitalization and AI along the entire pharma R&D value chain, and I’m very glad to welcome METiS as the first Roche Accelerator portfolio start-up focusing on AI."

Flagship Pioneering Unveils Sonata Therapeutics to Harness Cellular Microenvironments for the Treatment of Serious Diseases

On May 18th, 2022, Inzen Therapeutics merged with Cygnal Therapeutics to create Sonata Therapeutics (Press release, Inzen Therapeutics, MAY 18, 2022, View Source [SID1234635157]).

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Despite the recognized importance of the microenvironment to biology and disease, the networks of its inputs, constituents, and targets have never been fully characterized or understood. Sonata’s product-platform creates drugs based on a systematic, comprehensive characterization of the microenvironment in diseases with high unmet medical need.

Through its pioneering science, Sonata identifies new targets for therapeutics that induce the release of a programmed diversity of signals that drive curative microenvironments. Sonata uses a combination of proprietary pharmacologic and genetic perturbations, high-throughput and co-culture assays, phenotypic analyses, and machine learning, to enable target discovery.

Sonata is generating a growing pipeline of small molecule drugs and genetic therapeutics. Currently, the company’s pipeline includes six preclinical programs that address a broad range of oncologic indications, as well as exploratory efforts in fibrosis and autoimmune disorders.

"Sonata is taking an exciting and innovative approach to unlocking the enormous value potential of the cellular microenvironment," said Doug Cole, M.D., Managing Partner at Flagship and Chairman of Sonata’s Board of Directors. "It has the scale, technology, and team to translate the longstanding promise of the microenvironment into therapeutics that help patients with serious diseases."

Sonata Therapeutics was formed by combining two Flagship companies, Inzen Therapeutics and Cygnal Therapeutics, and builds on each company’s pioneering work characterizing different inputs into the cellular microenvironment and their roles in causing disease, and developing therapeutic strategies based on these insights.

Noubar Afeyan, Ph.D., Flagship Pioneering Founder and CEO, added, "Flagship’s focus on pioneering breakthroughs in human health, is embodied in the groundbreaking work of both Inzen and Cygnal. As the companies grew and their science advanced, their shared vision to reprogram the cellular microenvironment became clear. Sonata combines the expertise, resources, and vision of both companies to build a single stronger entity."

Former Inzen Chief Executive Officer, Volker Herrmann, M.D., has taken on the role of Sonata’s CEO. Former Cygnal CEO, Pearl Huang, Ph.D., recently announced her departure from the company to pursue new opportunities.

Volker Herrmann, M.D., Sonata CEO and Flagship Pioneering CEO-Partner added, "Remodeling the microenvironment requires the simultaneous control of a diversity of signals. Sonata Therapeutics’ unique approach harnesses these signals to develop curative treatments for serious diseases. I look forward to overseeing and accelerating Sonata’s growth and its transformative approach to medicine."

DEFENCE’S NOVEL ACCUVAC-PTE7 VACCINE SHOWS COMPLETE PROTECTION FROM CERVICAL CANCER

On May 18, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceuticals company primarily focussed on the development of novel immune-oncology vaccines and drug delivery technologies, is pleased to reported the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors (Press release, Defence Therapeutics, MAY 18, 2022, View Source [SID1234626249]).

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The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing.

Since the AccumTM molecule was previously shown to significantly enhance the immunogenicity of various proteins, the Defence team engineered a novel protein-based vaccine targeting the oncogenic protein E7 normally used by HPV to transform healthy cells into an outgrowing tumor. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immunecheckpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47.

"The idea of having a dual-acting vaccine targeting cervical cancer capable of both protecting and treating patients from cervical cancer is a giant step in the field of cancer vaccines. In addition, this vaccine contains a single protein, the E7, which makes it easier to manufacture and use compared to a mix of 9 proteins as provided by the Gardasil-9 product", says Mr. Plouffe, the CEO of Defence Therapeutics.

According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%