On July 27, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter ended June 30, 2021 (Press release, Dr Reddy’s, JUL 27, 2021, View Source [SID1234585225]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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* Q4 FY21 financials have been adjusted with an additional charge of Rs. 191 Cr ($ 26.25 mn) arising out of the arbitration award in favor of Hatchtech towards the Xeglyze product as an adjusting subsequent event for filing IFRS financials with US SEC in Form 20F on June 30, 2021.

Commenting on the results, Co-Chairman & MD, G V Prasad said "The financial performance of the quarter has been driven by healthy sales growth. I am confident about improving our margins in the upcoming quarters which will be led by the scale up of recent launches, new product launches and productivity. While we continue to sharpen execution in our core business, we are also conducting pilots in areas such as Nutrition, Direct-to-Customer, and Digital Health & Wellness, which can be future growth drivers".

COVID portfolio

We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Some of our major Covid-19 products are:

Sputnik V vaccine: We launched the vaccine in India in May 2021 after receiving Emergency Use Authorization (EUA) in April 2021. We are working with RDIF for ramping up supplies. We are also working with six CMOs in India for manufacturing readiness. We have launched it across 80 cities and 2.5+ Lakh people have been vaccinated so far. We are also working on Sputnik Light, for which Russia phase 3 trials will be leveraged for India approval as per recommendation from SEC.

Remdesivir: We launched it in India and ramped up our supplies in this quarter to meet with the higher demand due to surge of the COVID cases during the second wave in India.

Avigan (Favipiravir): We launched it in India and also in few other markets.

2-deoxy-D-glucose (2-DG): We developed it in collaboration with DRDO lab and received EUA as adjunct therapy for hospitalized moderate to severe Covid-19 patients. We have launched it in India in June 2021.

Molnupiravir: We are collaborating with 5 other pharmaceutical companies for the clinical trial of the investigational oral anti-viral drug for the treatment of mild Covid-19 in an outpatient setting in India.

Other Covid drugs: We are also working on Baricitinib and several other covid drugs for treatment ranging from mild to severe conditions.

Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 41.1 billion:

ØYear-on-year growth of 17% was driven primarily by branded markets (India and emerging markets) and Europe. The overall growth was on account of new product launches and volume traction in the base business, partly offset by price erosion in some of our products and adverse forex rates.

ØSequential growth of 6% driven by higher sales in India. The overall growth was attributable to higher volumes and new product launches, offset partially due to price erosion in certain products.

North America

Revenues from North America at Rs. 17.4 billion:

ØYear-on-year growth of 1%, driven by launch of new products and increase in volumes of certain of our existing products, which was offset by price erosion in some molecules and adverse forex rates.

ØSequential decline of 1%, on account of price erosion in some of our products, partially offset by volume traction and new products launched.

ØDuring this quarter, we launched 6 new products. These were Sapropterin Dihydrochloride Powder, Albendazole Tablets, Ertapenem Injection and Icosapent Ethyl Capsules in the US and two products in Canada.

ØWe filed two new ANDAs during the quarter. As of 30th June 2021, cumulatively 93 generic filings are pending for approval with the USFDA (90 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 93 pending filings, 47 are Para IVs and we believe 24 have ‘First to File’ status.

Europe

Revenues from Europe at Rs. 4.0 billion. Year-on-year growth of 12% and sequential growth of 1% was primarily on account of volume traction in base business and new product launches across our markets, which was partially offset by price erosion.

India

Revenues from India at Rs. 10.6 billion:

ØYear-on-year growth of 69% and sequential growth of 26% was primarily driven by increase in sales volumes of our existing products, led by increase in sale of covid drugs due to the severe second wave witnessed in India. The growth was also aided by contribution from new product launches and increase in sales prices of our existing products.

ØWe launched six new products during the quarter including Sputnik-V vaccine and 2-deoxy-D-glucose for covid. We also launched Curhealth, a nutritional health mix for building immunity.

Emerging Markets

Revenues from Emerging Markets at Rs. 9.1 billion. Year-on-year growth of 14% and sequential growth of 3%:

ØRevenues for Russia at Rs. 3.5 billion. Year-on-year growth of 8% was on account of increase in volumes and sales prices in our existing products and new products launches. Sequential decline of 13% was on account of lower volumes, offset partly by increase in sales price of certain products and new products launched.

ØRevenues from other CIS countries and Romania at Rs. 1.4 billion. Year-on-year growth of 4% driven by new product launches, offset partially by a reduction in sales volumes and prices of certain of our existing products. Sequential decline of 24% was on account of reduction in volumes and price of some of our existing products, offset partly by new products launched.

ØRevenues from Rest of World (RoW) territories at Rs. 4.2 billion. Year-on-year growth of 25% and sequential growth of 43% was largely attributable to new products launched and volume traction in our base business, partially offset by a reduction in sales prices of some of our products.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 7.5 billion. Year-on-year decline of 12% and sequential decline of 5%.

ØThe decline was on account of a decrease in sales volumes and prices of our existing products, partially offset by new products launched. Year-on-year was also impacted due to customer stocking up in last year.

ØDuring the quarter we filed DMFs for two products in the US.

Proprietary Products (PP) & Others

Revenues from PP & Others at Rs. 541 million. Year-on-year growth of 1% and sequential decline of 14%.

Income Statement Highlights:

ØGross profit margin for the year at 52.2%:

-Decreased by ~380 bps over previous year and by ~150 bps sequentially, majorly on account of price erosion and increase in inventory provisions related to few products. Q1 FY 21 was higher due to higher export incentives and favourable product mix.

-Gross profit margin for GG and PSAI business segments are at 57.7% and 21.6% respectively.

ØSelling, general & administrative (SG&A) expenses at Rs. 15.0 billion, increased by 18% on a year-on-year basis and by 5% sequentially. This increase was primarily attributable to investments being done towards marketing of some of our key brands, investments in digitalization and annual increments. The year-on-year increase is also due to additional expenses incurred with the integration of Wockhardt acquired portfolio.

ØResearch & development (R&D) expenses at Rs. 4.5 billion. As % to revenues – Q1 FY22: 9.2% | Q4 FY21: 8.7% | Q1 FY21: 9.0%. We continue our focus on investing in R&D to build a healthy pipeline of new products across our markets including development of biosimilars and products pertaining to COVID-19 treatment.

ØOther operating income at Rs. 487 million compared to Rs. 118 million in Q1 FY21. The increase was on account of certain settlements and other income during the quarter.

ØNet Finance income at Rs. 652 million compared to Rs. 605 million in Q1 FY21.

ØProfit before Tax at Rs. 7.4 billion, declined by 16% year-on-year and increased by 21% sequentially.

ØProfit after Tax at Rs. 5.7 billion. The effective tax rate is 23.1% for the quarter.

ØDiluted earnings per share is at Rs. 34.34.

Other Highlights:

ØEBITDA is at Rs. 10.2 billion and the EBITDA margin is 20.7%.

ØCapital expenditure is at Rs. 3.2 billion.

ØFree cash-outflow is at Rs. 6.8 billion.

ØNet cash surplus for the company is at Rs. 451 million as on June 30, 2021. Consequently, net debt to equity ratio is (0.003).

Earnings Call Details (05:30 pm IST, 08:00 am EDT, July 27, 2021)

The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

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Transcript: Transcript of the Earnings call will be available on the Company’s website: www.drreddys.com

On July 27, 2021 Novartis reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer (Press release, Novartis, JUL 27, 2021, View Source [SID1234585224]). NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ), which is known to have an important role in metastatic pancreatic ductal carcinoma (mPDAC) and other solid tumors.

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Pancreatic cancer has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment. The 5-year overall survival rate is approximately 11% in the US1, with few novel approaches advancing in the clinic and targeted and immunotherapy agents having shown limited activity.

NIS793 is a fully human anti-TGF-β IgG2 monoclonal antibody designed to inhibit the TGF-β pathway in tumor cells and to modulate the tumor microenvironment. In preclinical models, inhibiting TGFβ can reduce fibrosis characteristic of pancreatic and other solid tumor types, as well as enhance the response to chemotherapy and immunotherapy.
NIS793 has shown proof of mechanism and acceptable safety profile in a first in-human trial in patients with advanced solid tumors2 and is in development for pancreatic cancer and other solid tumor types. A Phase II study is ongoing, and a Phase III trial in 1L mPDAC is planned to start enrolling patients later this year.

An ODD grants special status to a drug being developed to treat a rare disease or condition, and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these diseases.3

On July 27, 2021 ImmunityBio, Inc., a publicly traded immunotherapy company, reported that it has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine (U.S. Patent 11,071,774) (Press release, ImmunityBio, JUL 27, 2021, View Source [SID1234585222]). This novel investigational treatment for cancer is designed to bolster a patient’s own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer’s resistance, and induce long-term T-cell memory to induce remission across multiple tumor types.

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The NCV has been in clinical testing since 2017 and has its foundation in earlier work that led to the development of Abraxane, an albumin nanoparticle that enables the delivery of paclitaxel to the tumor microenvironment. The basis of the orchestrated, multi-modal NCV approach is delivery of chemotherapy agents in a ‘metronomic’ fashion—low doses spread over time—to expose the tumor to immune system recognition by release of tumor-specific antigens. The tumor antigens are then targeted by antigen-specific T-cells activated via ImmunityBio’s adenoviral- and yeast-based vaccine vectors. T cell activation can then be enhanced further by infusion of the company’s proprietary, off-the-shelf, natural killer cell platform and its IL-15 superagonist N-803 (Anktiva).

To study the safety and early efficacy signals across multiple tumor types, the company has launched a series of Quantitative Lifelong Trials (QUILT). To date, the NANT Cancer Vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial studying the NCV in metastatic pancreatic cancer patients. Enrollment of Cohort C, patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.

"We are excited to be developing this orchestrated approach to activate as many elements of the immune system that we can and overcome cancer’s ability to evade the immune system. Our hypothesis is that by revealing tumor antigens to the immune system, we activate tumor-specific T cells and targeted natural killer cells to eradicate tumors by what is known as immunogenic cell death," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "The issuance of the NANT Cancer Vaccine patent is recognition of this innovative approach to therapy that not only potentially provides long-term immune system protection from cancer, it does so with a reduced risk of the toxicity risk that comes with using high-dose chemotherapy and radiation. This closely aligns with the FDA’s recent ‘Project Optimist’ guidelines for exploring lower doses of therapeutic agents."

ImmunityBio’s intellectual property portfolio includes more than 1,100 issued and pending patents worldwide across multiple categories including biologics, vaccine vectors, natural killer cells, and GMP devices. Patents for key areas such as N-803 (Anktiva), adenovirus vaccine vectors, yeast vaccine vectors, NK-92 cells and therapies extend to 2035 and beyond.

On July 27, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for KVA12.1 (Press release, Kineta, JUL 27, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-pre-ind-meeting-for-kva12-1 [SID1234585217]). Kineta has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of Kineta’s KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumors.

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"We greatly appreciate the FDA’s guidance as we prepare to advance our novel anti-VISTA immunotherapy into the clinic next year", said Shawn Iadonato, PhD, Chief Executive Officer of Kineta. "The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for KVA12.1 and confidence with the planned development program for this novel anti-cancer immunotherapy.

A pre-IND meeting provides an opportunity for an open communication between a drug development company and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies of the company’s new drug candidate. The FDA reviewed the IND enabling preclinical data, manufacturing plan and phase 1/2 clinical study protocol synopsis for KVA12.1, provided guidance and addressed Kineta’s questions on the development plan. Kineta plans to initiate the Phase 1/2 first-in-human clinical studies in mid-2022.

On July 27, 2021 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which has been shown to reverse a fundamental biologic mechanism of immune suppression in cancer and activate an anti-tumor immune response, reported that data updates from MARIO-275, the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with nivolumab (Opdivo) in platinum-refractory, I/O naïve patients with advanced UC as well as data from MARIO-3, the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination in the front-line setting with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in patients with unresectable locally advanced or metastatic TNBC (Press release, Infinity Pharmaceuticals, JUL 27, 2021, View Source [SID1234585216]).

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Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals, said, "Today we report data indicating that eganelisib re-programs macrophages in the tumor microenvironment, turning pro-tumor, M2, macrophages into anti-tumor, M1, macrophages and improves outcomes for patients in two distinct types of cancer. Specifically, when combined with current standard of care therapies, the data showed that eganelisib increased overall survival in patients with metastatic urothelial cancer and prolonged progression free survival in patients with TNBC. These data provide preliminary, but compelling evidence of eganelisib’s potential to improve outcomes for patients with these two types of cancer. Validation of the fundamental biologic hypothesis of eganelisib, and the resulting prospect of patient benefit, gives us great confidence in the future of eganelisib, Infinity and our ability to realize our vision of bringing better therapies to patients. In the months ahead, Infinity plans to work with investigators, key opinion leaders and regulatory authorities to carefully choose the most appropriate clinical paths forward and expects to provide an update by year end, together with an update on our maturing TNBC data."

Brian Schwartz, M.D., consulting Chief Physician, Infinity Pharmaceuticals, said, "The promising survival benefit was noted after over a year of following MARIO-275 patients versus the control arm as well as compared to historical trials including CheckMate-275, particularly given the magnitude of the unmet need in 2L UC, including in the PD-L1 negative patient population. These results are reinforced by the progression free survival data which we presented at ASCO (Free ASCO Whitepaper) GU in February 2021 as well as the translational data that support our thesis that eganelisib reprograms macrophages in the tumor microenvironment and that validate eganelisib’s mechanism of action. We believe overall survival represents a key registrational endpoint, and given these exciting new OS data, we are exploring the optimal study design for a potential registration study and expect to provide a program update by the end of 2021."

Erika Hamilton, M.D., Director, Breast Cancer and Gynecologic Cancer Research Program, Tennessee Oncology, and Lead Study Investigator for MARIO-3, said, "The emerging progression free survival data from MARIO-3 are very encouraging and suggest that the impressive disease control rate observed, regardless of PD-L1 status, is translating to a benefit in progression free survival. These results are consistent with the results from MARIO-275, which show the similar translation of disease control into a meaningful survival benefit for patients. For patients with TNBC, the potential to extend progression free survival, regardless of PD-L1 status, would be a transformational breakthrough. We are on track to complete enrollment by year end, and with the majority of patients still on treatment, look forward to presenting additional, more mature data at that time."

MARIO-275 Key Data Updates:

49 patients were enrolled in the trial with the last patient enrolled in June 2020.
Median overall survival (mOS) in the intent to treat (ITT) population was 15.4 months (6.2, NE) on the eganelisib plus nivolumab combination arm as compared to 7.9 months (2.3, NE) on the control arm of nivolumab alone with a hazard ratio of 0.62 (0.28, 1.36), which reflects a 38% lower probability of death on the combination arm.
At the one-year landmark, 59% of patients in the ITT population receiving the eganelisib plus nivolumab combination remained alive, compared to 32% in the nivolumab control arm.
The mOS benefit observed in patients with PD-L1(-) tumors was the same as in the ITT population, with a mOS of 15.4 months (4.7, NE) on the eganelisib plus nivolumab combination arm as compared to 7.9 months (1.9, NE) on the control arm of nivolumab alone with a hazard ratio of 0.60 (0.21, 1.71), which reflects a 40% lower probability of death on the combination arm.
At the one-year landmark, 54% of the patients with PD-L1(-) tumors receiving the eganelisib plus nivolumab combination remained alive, compared to 17% in the nivolumab control arm.
The most common treatment emergent adverse events (TEAEs) across all doses, all causality, were pyrexia (33.3%), decreased appetite (30.3%), pruritus (27.3%), asthenia (27.3%), rash (27.3%), disease progression (27.3%) and increased alanine aminotransferase (24.2%); and the most common ≥Grade 3 TEAEs across all doses, all causality, were disease progression (27.3%), anemia (12.1%), and hepatic AEs including hepatotoxicity (15.2%), increased ALT (12.1%) and increased AST (12.1%) with no Hy’s Law. No Grade 5 hepatic AEs were reported.
Translational data: Gene expression studies from peripheral blood, followed by gene set enrichment analysis using Hallmark gene signature sets show the pro-inflammatory interferon gamma and interferon alpha pathways were the most significantly enriched pathways in the combination arm when comparing Day 15 to baseline, regardless of PD-L1 status, with higher enrichment scores and lower p values than on the control arm. These data are consistent with eganelisib’s mechanism of action which decreases immune suppression and increases immune activation.
MARIO-3 Key Data Updates:

This data update includes 43 patients enrolled with 38 evaluable, which compares to 20 patients enrolled with 13 evaluable at our update at the San Antonio Breast Cancer Symposium in December 2020.
86.8% (33/38) of evaluable patients demonstrated tumor reduction.
Disease control rate (DCR)
78.2% (18/23) DCR in patients with PD-L1 negative tumors: complete response (CR) 0% (0/23), partial response (PR) 47.8% (11/23), stable disease (SD) 30.4% (7/23)
91.7% (11/12) DCR in patients with PD-L1 positive tumors: CR 16.7% (2/12), PR 50% (6/12), SD 25% (3/12)
84.2% (32/38) DCR in all patients: CR 5.3% (2/38), PR 50% (19/38), SD 28.9% (11/38)
Early progression free survival (PFS)
In patients with PD-L1(-) tumors, PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 5.6 months to 7.3 months (3.5, NA).
In patients with PD-L1(+) tumors, PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 7.5 to 11.2 months (5.3, 11.2).
In the ITT population, PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 7.2 months to 7.4 months (5.3, NA).
MARIO-3 did not demonstrate any new or additive safety signals compared to benchmark trials. The most common TEAEs, all causality, were nausea (51.2%), fatigue (48.8%), alopecia (32.6%), diarrhea (32.6%), rash maculo-papular (30.2%) increased ALT (27.9%) with only one Grade 4 and increased AST (25.6%) with one grade 4. No Hy’s Law or Grade 5 hepatic AEs were reported, and only one patient permanently discontinued study treatment due to an elevated liver function test.
Quantification across 11 paired tumor biopsies shows increased immune activation and decreased immune suppression including an increase in CD8+ T cells, activated T cells, and anti-tumor M1 macrophages and a decrease in tumor cells and pro-tumor M2 macrophages resulting in an increase in the M1:M2 ratio.
Paired tumor biopsy data show 5 of 8 patients with PD-L1(-) tumors converting to PD-L1(+) two months after treatment utilizing the 1% PD-L1 cutoff standard. PD-L1 expression also increased in the three patients with PD-L1(+) tumors who started the study above the 1% cutoff. None of the patients converting to PD-L1(+) or patients with PD-L1(+) tumors who experienced increased PD-L1 expression had disease progression.
KOL Event Information

In lieu of an earnings conference call, Infinity will host a KOL event today, July 27, 2021, at 8:00AM ET to provide updates on the MARIO-3 TNBC and MARIO-275 UC clinical studies. Erika P. Hamilton, M.D. of Sarah Cannon Research Institute at Tennessee Oncology, and MARIO-3 lead investigator, and Brian Schwartz, M.D., Consulting Chief Physician of Infinity, will review the data for MARIO-3 and MARIO-275, respectively.