On May 14, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the first quarter ended March 31, 2021 (Press release, Mustang Bio, MAY 14, 2021, View Source [SID1234580016]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the first quarter of 2021, we successfully executed our clinical and regulatory strategies and achieved milestones that we believe will drive Mustang’s continued progress. We announced encouraging MB-107 and MB-207 clinical updates from our investigator-IND trials for X-Linked Severe Combined Immunodeficiency ("XSCID"), as well as additional consistent safety and efficacy data pertaining to our lentiviral vector gene therapies that we have seen over the more than eight years since the first patient was treated in 2012. In January, the U.S. Food and Drug Administration ("FDA") lifted a Chemistry, Manufacturing and Controls ("CMC") hold on the MB-107 Investigational New Drug ("IND") application for newly diagnosed infants under the age of two and we expect to dose the first infant in the multicenter trial soon. We also plan to file an IND for our MB-207 clinical trial for patients with XSCID who have been previously treated with hematopoietic stem cell transplantation ("HSCT") and for whom re-treatment is indicated."

Dr. Litchman continued, "Notably, we are thrilled with the progress of our MB-106 CD20-targeted CAR T cell therapy program for relapsed or refractory CD20+ B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"). Earlier this month, we announced that the FDA approved Mustang’s IND to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 for relapsed or refractory CD20+ B-NHL and CLL. Also, we look forward to the Fred Hutchinson Cancer Research Center presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 ("EHA2021") Virtual Congress next month, where Dr. Mazyar Shadman will present updated interim data from their ongoing CD20-targeted CAR T clinical trial. We are very pleased to have three active Mustang-sponsored INDs, and we anticipate having four active Mustang-sponsored INDs by the end of the year."

Financial Results:

As of March 31, 2021, Mustang’s cash and cash equivalents and restricted cash totaled $130.4 million, compared to $98.8 million as of December 31, 2020, an increase of $31.6 million year-to-date.
Research and development expenses including license acquisitions were $11.6 million for the first quarter of 2021, compared to $9.6 million for the first quarter of 2020. Non-cash, stock-based expenses included in research and development were $0.7 million for the first quarter of 2021, compared to $0.4 million for the first quarter of 2020.
General and administrative expenses were $3.5 million for the first quarter of 2021, compared to $2.0 million for the first quarter of 2020. Non-cash, stock-based expenses included in general and administrative expenses were $1.5 million for the first quarter of 2021, compared to $0.5 million for the first quarter of 2020.
Net loss attributable to common stockholders was $15.0 million, or $0.19 per share, for the first quarter of 2021, compared to a net loss attributable to common stockholders of $11.9 million, or $0.28 per share, for the first quarter of 2020.
Recent Corporate Highlights:

In February 2021, Mustang announced encouraging MB-107 and MB-207 clinical updates from its investigator-IND XSCID trials, as well as additional consistent safety and efficacy data. On January 28, 2021, the FDA removed a CMC hold on the MB-107 Phase 2 clinical trial IND after reviewing a comprehensive CMC package that was submitted by Mustang in late December 2020. The company expects to enroll the first patient in this pivotal multicenter trial in the second quarter of 2021 and is targeting topline data from the trial in the second half of 2022. The company also expects to file an IND in the second quarter of 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207.
In May 2021, Mustang announced that the FDA approved its IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T therapy for high-risk B-NHL and CLL.
Also in May 2021, Mustang announced that CD20-targeted CAR T therapy data were selected for presentation at the EHA (Free EHA Whitepaper)2021 Virtual Congress scheduled to take place in June. Dr. Mazyar Shadman of Fred Hutch will present updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. A copy of the abstract can be viewed online through the EHA (Free EHA Whitepaper)2021 website here.

On May 14, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported that Jason Gardner, D.Phil., President and Chief Executive Officer, will participate in fireside chats at the following investor conferences this month (Press release, Magenta Therapeutics, MAY 14, 2021, View Source [SID1234580015]):

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Cowen 2nd Annual Virtual Oncology Innovation Summit on Thursday, May 20, at 10:40 a.m. ET
Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, at 2:55 p.m. ET
Live webcasts of the fireside chats can be accessed on the Magenta Therapeutics website at View Source The webcast replays will be available for 90 days following each event.

On May 14, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2021 (Press release, Leap Therapeutics, MAY 14, 2021, View Source [SID1234580014]).

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Leap First Quarter Highlights:

Completed enrollment for first-line patient cohort in the DisTinGuish study, a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ)
Presented updated clinical data from the Phase 2 study of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology (SGO) 2021 Virtual Annual Meeting on Women’s Cancer
Announced partnership to use a clinically validated tumor expression assay utilizing RNAscope and image analysis with Flagship Biosciences for patient enrollment
"We’re off to a strong start this year as we’ve continued to advance our understanding of DKN-01 and the potential role it can play as both a monotherapy or in combination with existing treatments in multiple DKK1 biomarker defined cancer indications," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The completion of enrollment of the first-line patient cohort in the DisTinGuish study brings us one step closer to an important milestone for us with our partner BeiGene, anticipated later this year."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which have an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Leap Announced Completion of Enrollment in First-Line Cohort in the DisTinGuish Study of DKN-01 plus Tislelizumab and Chemotherapy in Gastric Cancer – In April 2021, Leap announced the completion of enrollment for the first-line patient cohort in the DisTinGuish study (NCT04363801), a clinical trial evaluating DKN-01 in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, with or without chemotherapy, in patients with G/GEJ. The study, which is being conducted in two parts in the United States and the Republic of Korea, enrolled 25 patients with first-line G/GEJ cancer and will enroll up to 48 patients with second-line G/GEJ cancer whose tumors express high levels of DKK1. Initial data is expected in the second half of 2021. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Leap Presented Final Data for DKN-01 in Gynecologic Cancers – At the SGO 2021 Virtual Annual Meeting on Women’s Cancer, Leap presented the final data from the study of DKN-01 as a monotherapy or in combination with paclitaxel in groups composed of epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (MMMT) patients. The key findings from the study were:

EEC patients and patients with Wnt activating mutations express higher levels of DKK1: EEC patients expressed higher levels of DKK1 and had a higher frequency of Wnt activating mutations than patients with EOC. Within EEC, patients with endometrioid histology had higher DKK1 expression than those with non-endometrioid histology. Patients whose tumors had Wnt activating mutations expressed 14.4 times higher levels of DKK1.

DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 22 EEC patients treated with DKN-01 monotherapy for whom DKK1 expression data was available, patients with DKK1-high tumors (n=7) had greater ORR (14% vs. 0%), DCR (57% vs. 7%), and median PFS (3.0 months vs. 1.8 months [HR 0.39; 95% CI: 0.14, 1.1]) compared to patients with DKK1-low tumors (n=15). Additionally, seven patients did not have DKK1 expression results available, of whom one had a complete response (14%) and five (72%) had a best response of stable disease, including three patients with Wnt activating mutations. In the group of 24 EEC patients treated with DKN-01 plus paclitaxel, 72% of whom had received three or more prior systemic therapies, DKK1-high patients (n=11) had improved median PFS (5.4 months vs. 1.8 months [HR 0.34; 95% CI: 0.12, 0.97]) compared to DKK1-low patients (n=9). Four patients did not have DKK1 expression data available.

Presented DKK1 Biomarker Assay Validation Data – At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, Leap and its clinical laboratory partner, Flagship Biosciences, presented data on the validation of a DKK1 RNAscope chromogenic in situ hybridization (CISH) assay and digital image analysis solution. Leap and Flagship have demonstrated that the DKK1 RNAscope assay and accompanying digital image analysis solution is specific, sensitive, accurate and reproducible according to Clinical Laboratory Improvements Amendments (CLIA) guidelines. The assay is currently being used to prospectively identify G/GEJ patients with elevated tumoral expression of DKK1 in the ongoing DisTinGuish clinical trial.
Selected First Quarter 2021 Financial Results

Net Loss was $9.1 million for the first quarter 2021, compared to $7.2 million for the same period in 2020. This increase was primarily due to increased development activity for the DKN-01 program and an increase in headcount and compensation expense as the Company has grown throughout the year.

License revenues for each of the first quarter 2021 and 2020 were $0.4 million, and relate to the BeiGene Agreement for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. The BeiGene Agreement became effective on January 3, 2020.

Research and development expenses were $6.8 million for the first quarter 2021, compared to $4.6 million for the same period in 2020. The increase of $2.2 million in research and development expenses was primarily due to an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full time employees, an increase of $0.6 million in manufacturing costs related to clinical trial material and an increase of $0.8 million in clinical trial costs due to timing of patient enrollment.

General and administrative expenses were $2.7 million for the first quarter 2021, compared to $2.2 million for the same period in 2020. The increase of $0.5 million in general and administrative expenses was due to a $0.3 million increase in payroll and other related expenses during the three months ended March 31, 2021 as compared to the same period in 2020 and a $0.2 million increase in professional fees primarily due to increased recruiting and information technology costs.

Cash and cash equivalents totaled $43.5 million at March 31, 2021. Research and development incentive receivables totaled $0.02 million at March 31, 2021.

On May 14, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported financial results for the first quarter ended March 31, 2021 (Press release, Forma Therapeutics, MAY 14, 2021, View Source [SID1234580013]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"During the first quarter, we successfully completed the multiple ascending dose portion of our Phase 1 trial in sickle cell disease, and despite challenges from the COVID-19 pandemic also began enrolling patients in the Phase 2/3 trial of FT-4202, called The Hibiscus Study, as well as in the Phase 1 trial of FT-7051 for metastatic castration resistant prostate cancer," said Frank Lee, President and Chief Executive Officer of Forma. "We look forward to sharing additional pipeline results over the course of 2021 in our mission to transform the lives of people living with rare hematologic diseases and cancers."

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

MAD cohorts completed with approximately 71% of participants achieving hemoglobin increase ≥ 1 g/dL from baseline, and improvement across markers of RBC health. Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed. Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and lactate dehydrogenase) parameters were comparable to that observed with the 300 mg dose, with best response typically observed at the end of the 14-day treatment period. In the combined cohorts, 10 of 14 (71%) patients on FT-4202 achieved a hemoglobin increase ≥ 1 g/dL from baseline to Day 14. Improvement in RBC health was evidenced by increased sickle RBC survival and reduced intravascular hemolysis in patients with SCD based on a reduction in reticulocytes, bilirubin and LDH levels.
Patient enrollment began in Phase 2/3 registrational trial, the Hibiscus Study. The Phase 2/3 Hibiscus Study is currently enrolling people living with SCD. This adaptive, randomized, placebo-controlled, double-blind, multi-center trial is expected to enroll approximately 344 adults and adolescents with SCD. FT-4202 doses of 200mg and 400mg administered once-daily are being evaluated in the Phase 2 portion of the trial. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), intended to support accelerated approval, and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period, which if positive is expected to support full approval.
CPB/p300 Program in Prostate Cancer:

FT-7051 Phase 1 clinical trial initiated for the treatment of mCRPC. In January 2021, Forma announced that the first patient was dosed in the ongoing Phase 1 clinical trial evaluating FT-7051 for the treatment of mCRPC. The trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (prostate specific antigen (PSA) and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The trial will include genetic mutation analysis to identify the basis of resistance to standard-of-care and will also evaluate expression of the AR-v7 splice variant, for which there are no approved therapies. The trial utilizes an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information, as well as to identify biomarkers of clinical benefit such as PSA response.
IDH1 Program in AML and Glioma:

Olutasidenib NDA preparation for R/R AML. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing an NDA for submission to the U.S. Food and Drug Administration (FDA).
Upcoming Milestones

Presentation of updated Phase 1 FT-4202 results in SCD. A poster presentation on FT-4202 in SCD is scheduled for the EHA (Free EHA Whitepaper) Virtual Congress taking place June 9-17, 2021. The presentation will include combined unblinded data from the two-week MAD cohorts as well as initial OLE results to date. In addition, full results from the MAD dose cohorts and the OLE are expected to be presented at a scientific congress in late 2021.
Initial Phase 1 clinical results from FT-7051 in mCRPC anticipated later this year. This adaptive trial is assessing multiple doses of FT-7051 with dose escalation dependent upon safety and tolerability. Initial results anticipated in the fourth quarter of 2021 may include safety/tolerability, PK/PD results and preliminary biomarker data.
Olutasidenib results presentation in R/R AML. Phase 2 registrational results of olutasidenib in R/R AML will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting taking place from June 4-8, 2021, and the EHA (Free EHA Whitepaper) Virtual Congress taking place June 9-17, 2021.
Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry, including ours, have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $603.7 million as of March 31, 2021, as compared to $645.6 million as of December 31, 2020. Current cash runway is projected through the third quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses were $26.3 million for the quarter ended March 31, 2021, compared to $23.2 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in FT-4202 development expenses, partially offset by reduced spending on olutasidenib development.
General and Administrative (G&A) Expenses: G&A expenses were $9.9 million for the quarter ended March 31, 2021, compared to $8.9 million for the quarter ended March 31, 2020. The increase in general and administrative expense was primarily attributable to stock compensation expense and insurance, partially offset by a reduction in professional fees.
Net Income/Loss: Net loss was $36.0 million for the quarter ended March 31, 2021, compared to net income of $11.2 million for the quarter ended March 31, 2020.
Forma will conduct a conference call and webcast May 14th at 8 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2021 results and business update. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 8597396.

On May 14, 2021 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, 2021 (Press release, Dr Reddy’s, MAY 14, 2021, View Source [SID1234580010])
. The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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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: The trials demonstrated efficacy @ 91.6%, consistent safety and immunogenicity results. In April, 2021 we received Emergency Use Authorization (EUA) for the vaccine. We have launched it today and the first dose of the vaccine was administered. Our priority is to ensure widest reach in the shortest possible time.

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

Avigan (Favipiravir): We are selling it in India and few other markets. We are conducting phase 3 trials in North America for outpatient setting with mild to moderate symptoms. 2-deoxy-D-glucose (2-DG): We developed it in collaboration with DRDO lab. Received EUA as adjunct therapy for hospitalized moderate to severe Covid-19 patients.

Other Covid drugs: We are also working on Molnupiravir, Baricitinib and several other covid drugs for treatment ranging from mild to severe conditions. Revenue Analysis [Q4 and full year FY21] Global Generics (GG)
 Revenues from GG segment at Rs. 154.4 billion higher by 12% over FY20, on account of growth across all our markets. We witnessed double digit growth in Europe and India during the year.
Q4 revenue at Rs. 38.7 billion, YoY growth of 6% and QoQ decline of 5%. The YoY growth was driven by branded markets (India and emerging markets), Europe partly offset by decline in NAG. QoQ decline was on account of branded markets & Europe. North America 
Revenues from North America Generics for the year at Rs. 70.5 billion, YoY growth of 9%. The year was benefited by new launches, scale up of existing products and a favorable forex rate, which was partially offset by price erosion.
 Revenues for Q4 at Rs. 17.5 billion, YoY decline of 3% and QoQ growth of 1%. The YoY decline was primarily on account of higher volumes during Q4 last year due to COVID-19 related stocking up and price erosion. The QoQ growth was driven by volume traction in our base business and new product launches partly offset by price erosion.
 During this quarter, we launched 6 new products – Vigabatrin tablets (CGT status granted), Febuxostat tablets, Capecitabine tablets, Fluphenazine Hydrochloride tablets, Lansoprazole OD tablets and Abiraterone Acetate in Canada.
As of 31st March 2021, cumulatively 95 generic filings are pending for approval with the USFDA (92 ANDAs and 3 NDAs under 505(b)(2) route). Out of the pending ANDAs, 47 are Para IVs, and we believe 23 have ‘First to File’ status. Europe
 Revenues from Europe for the year at Rs. 15.4 billion. YoY growth of 32%, primarily on account of volume traction in base business, new product launches across our markets including newer markets of France, Italy and Spain and favorable fo ex, which was partially offset by price erosion. 7
 Revenues for Q4 at Rs. 4.0 billion, YoY growth of 15% and QoQ decline of 5%. QoQ decline was on account of lower volumes in our base business and price erosion which was partly offset by new products launched during the quarter. India
 Revenues from India for the year at Rs. 33.4 billion. Year-on-year growth of 15%, driven by revenues from the acquired business of Wockhardt and contribution from new product launches.
 Revenues for Q4 at Rs. 8.4 billion, YoY growth of 23%, QoQ decline of 12%. QoQ decline was led by reduction in covid drugs sales and seasonality. Emerging Markets
 Revenues from Emerging Markets for the year at Rs. 35.1 billion, growth of 7%.-Revenues from Russia for the year at Rs. 15.8 billion, YoY decline of 6%. The decline was primarily driven by adverse forex and lower volumes of some of our key molecules.-Revenues from other CIS countries and Romania for the year at Rs. 7.4 billion, YoY growth of 15%. Growth was on account of increase in volumes and new launches.-Revenues from Rest of World (RoW) territories for the year at Rs. 11.8 billion, YoY growth of 25%. Growth primarily on account of new launches and volume traction in key products, partially impacted by price erosion in certain markets.
 Revenues for the quarter are Rs. 8.8 billion, YoY growth of 10%, QoQ decline of 8%.-Revenues for Russia for the Q4 at Rs. 4.0 billion, YoY growth of 3%, QoQ decline of 11%.-Revenues from other CIS countries and Romania for the quarter are Rs. 1.9 billion, YoY growth of 7%, QoQ decline of 11%.-Revenues from Rest of World (RoW) territories for this quarter are Rs. 2.9 billion, YoY growth of 24%, QoQ decline of 1%. Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 32.0 billion. Year-on-year growth of 24% driven by new products, increase in volumes of key products of API business and favorable forex partially offset by price erosion.
 Revenues for Q4 at Rs. 7.9 billion, YoY growth of 10% and QoQ growth of 13%.
 During the year, we have filed 14 DMFs in the US. Proprietary Products (PP) & Others  Revenues from PP & Others for the year at Rs. 3.3 billion, YoY decline of 69%. FY20 was higher due to income from sale of the US and select territory rights for two of Neurology franchise products pertaining to PP.  Revenues for Q4 are Rs. 632 million. 8 Income Statement Highlights:  Gross profit margin for the year at 54.3%, an increase of ~50 bps over previous year. The increase was driven by a better product mix and increased leverage from manufacturing overheads. This was partly offset by price erosion, lower export incentives and benefit from PP out-licensing income in FY 20. Gross profit margin for GG and PSAI business segments are at 59.0% and 29.5% respectively. 
Gross profit margin for the Q4 at 53.7% (GG: 57.9%, PSAI: 31.7%).-YoY gross margin increased by ~220 bps, primarily due to a better product mix and increased leverage from manufacturing overheads, partly offset by price erosion and lower export benefits-QoQ gross margin declined by ~10 bps.  Selling, general & administrative (SG&A) expenses for FY21 at Rs. 54.6 billion, an increase of 9% on a YoY basis. This increase was primarily due to incremental costs post the integration of the acquired divisions from Wockhardt in this year and increased freight expenses. SG&A expenses for Q4 at Rs. 14.3 billion, YoY increase of 17% and QoQ decline of 1%. SG&A as a % to sales for the full year remained in line with FY20.  Impairment charge at Rs. 6.8 billion in FY21, which were taken considering the triggers which occurred during the year.  Research & development (R&D) expenses in FY21 at Rs. 16.5 billion. As % to Revenues – FY21: 8.7% | FY20: 8.8%. R&D expenses for Q4 at Rs. 4.1 billion, as % to revenues stood at 8.7%. Our focus continues on building a healthy pipeline of new products across our markets including development of products pertaining to COVID-19 treatment.  Other operating income for the year at Rs. 982 million compared to Rs. 4.3 billion in FY20. Previous year included Rs. 3.5 billion received from Celgene pursuant to a settlement agreement in Canada.  Net Finance income for the year at Rs. 1.7 billion compared to Rs. 1.5 billion in FY20. The increase is primarily on account of higher foreign exchange gain in current year as compared to FY20. Net finance income in Q4 is Rs. 0.3 billion.  Profit before Tax for the year at Rs. 28.3 billion, YoY growth of 57%. Profit before Tax for Q4 is at Rs. 8.1 billion. 

Profit after Tax for the year at Rs. 19.1 billion and for Q4 at Rs. 5.5 billion. The tax rate in FY21 is higher due to non-recognition of deferred tax asset (DTA) on losses arising out of impairment. It was lower in FY20 due to recognition of deferred tax asset (DTA) on losses arising out of impairment, recognition of MAT credit, and others in line with the requirements of accounting standards.  Diluted earnings per share for the year is Rs. 115.14. Diluted earnings per share for Q4 is Rs. 33.29. Other Highlights:  EBITDA for FY21 at Rs. 47.5 billion and the EBITDA margin is 25.0%. EBITDA for Q4 FY21 is at 11.3 billion and the EBITDA margin in 24.0%.  Capital expenditure for FY21 is at Rs. 9.7 billion. Capital expenditure for Q4 FY21 is at Rs. 2.9 billion.  Free cash-flow at Rs. 24.6 billion before acquisitions. Free cash-flow for Q4 FY21 at Rs. 7.9 billion.  Net cash surplus for the company is at Rs. 7.5 billion as on March 31, 2021. Consequently, net debt to equity ratio is (0.04).  The Board has recommended payment of a dividend of Rs. 25 per equity share of face value Rs 5/-each (500% of face value) for the year ended March 31, 2021 subject to approval of members. 9 Earnings Call Details (05:30 pm IST, 08:00 am EDT, May 14, 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.