On November 1, 2019 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2019 (Press release, AbbVie, NOV 1, 2019, View Source [SID1234550173]).

"Strong performance from our Immunology and Hematologic Oncology portfolios led our growth this quarter. We are also making excellent progress with several key strategic priorities, including the recent launch of our two new immunology therapies – Rinvoq and Skyrizi – both of which are off to an impressive start, as well as continued progress toward the completion of our planned acquisition of Allergan," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based on the continued momentum of our portfolio, we are once again raising our full year 2019 EPS guidance range and increasing our dividend."

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Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net
revenues at the prior year’s foreign exchange rates.

Third-Quarter Results

Worldwide net revenues were $8.479 billion, an increase of 3.0 percent on a reported basis, or 3.5 percent operationally.

Global HUMIRA net revenues of $4.936 billion decreased 3.7 percent on a reported basis, or 3.2 percent operationally. U.S. HUMIRA net revenues were $3.887 billion, an increase of 9.6 percent. Internationally, HUMIRA net revenues were $1.049 billion, a decrease of 33.5 percent on a reported basis, or 31.8 percent operationally, due to biosimilar competition.

Global net revenues from the hematologic oncology portfolio were $1.478 billion, an increase of 38.3 percent on a reported basis, or 38.5 percent operationally. Global IMBRUVICA net revenues were $1.257 billion, an increase of 29.3 percent, with U.S. net revenues of $1.042 billion and international profit sharing of $215 million. Global VENCLEXTA net revenues were $221 million.

Global HCV net revenues were $698 million, a decrease of 19.0 percent on a reported basis, or 18.6 percent operationally. In the U.S., HCV net revenues of $368 million decreased 17.0 percent in the quarter. Internationally, HCV net revenues of $330 million decreased 21.2 percent on a reported basis, or 20.4 percent operationally.

On a GAAP basis, the gross margin ratio in the third quarter was 77.4 percent. The adjusted gross margin ratio was 82.0 percent.

On a GAAP basis, selling, general and administrative expense was 19.5 percent of net revenues. The adjusted SG&A expense was 19.1 percent of net revenues.

On a GAAP basis, research and development expense was 26.9 percent of net revenues. The adjusted R&D expense was 14.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

On a GAAP basis, the operating margin in the third quarter was 30.9 percent. The adjusted operating margin was 48.4 percent.

On a GAAP basis, net interest expense was $420 million. The adjusted net interest expense was $288 million. On a GAAP basis, the tax rate in the quarter was 5.9 percent. The adjusted tax rate was 8.8 percent.

Diluted EPS in the third quarter was $1.26 on a GAAP basis, inclusive of an impairment charge related to intangible assets acquired as part of the 2016 acquisition of Stemcentrx, Inc. Adjusted diluted EPS, excluding specified items, was $2.33.

Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net
revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced the U.S. Food and Drug Administration (FDA) approval of RINVOQ (upadacitinib) for the treatment of moderate to severe rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate. The approval is based on results from the SELECT Phase 3 program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across five studies. Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for RINVOQ, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Discovered and developed by AbbVie, RINVOQ marks the second FDA approval of a targeted immunomodulator therapy for AbbVie this year.

AbbVie announced positive top-line results from its first Phase 3 clinical trial of RINVOQ in adult patients with active psoriatic arthritis. Results from the SELECT-PsA 2 study, which evaluated RINVOQ versus placebo in patients who did not adequately respond to treatment with one or more biologic DMARDs, showed that both doses of RINVOQ (15 mg and 30 mg) met the primary endpoint of ACR20 response at week 12. Key secondary endpoints were also achieved and included HAQ-DI, PASI75, minimal disease activity, ACR50 and ACR70. The safety profile was consistent with that of previous studies across indications, with no new safety signals detected. Detailed study results will be presented at an upcoming medical conference.

AbbVie presented new long-term data showing a significant number of patients with moderate to severe plaque psoriasis treated with SKYRIZI (risankizumab) experienced complete skin clearance. At the World Congress of Dermatology (WCD), AbbVie presented data from the Phase 3 IMMhance study which showed 73 percent of patients achieved a static Physician Global Assessment (sPGA) score of clear or almost clear skin and 72 percent of patients achieved a Psoriasis Area and Severity Index (PASI) 100 score at week 94, among patients who achieved sPGA 0/1 at week 28. At the European Academy of Dermatology and Venereology (EADV), AbbVie presented data from the Phase 3 LIMMitless trial which showed that at approximately 2.5 years of treatment SKYRIZI provides durable maintenance of efficacy with 87 percent of patients achieving PASI 90, 61 percent achieving PASI 100 and 86 percent achieving a sPGA score of clear or almost clear skin. SKYRIZI is part of a collaboration between Boehringer Ingelheim (BI) and AbbVie, with AbbVie leading development and commercialization globally.

AbbVie announced the FDA approval of MAVYRET (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes. Mavyret was previously approved by the FDA as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis. In addition, the European Commission (EC) approved MAVIRET (glecaprevir/pibrentasvir) for 8 weeks of treatment in treatment-naïve patients with chronic HCV and compensated cirrhosis with genotype 1, 2, 4, 5 and 6. The label expansions were based on data from the Phase 3b EXPEDITION-8 study in which an overall 98 percent of patients achieved a sustained virologic response 12 weeks after treatment.

AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced the submission of a New Drug Application (NDA) to the FDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women. In two replicate Phase 3 clinical studies, elagolix demonstrated a statistically significant reduction in HMB, in combination with add-back therapy, compared to placebo. If approved by the FDA, elagolix will be an oral medical management treatment option for HMB associated with uterine fibroids.

Recent Events (continued)

Following the closure of the MERU Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a first-line maintenance therapy for advanced small-cell lung cancer, the termination of the Rova-T research and development program and an evaluation of the Stemcentrx-related intangible assets, AbbVie recorded an impairment charge related to intangible assets acquired as part of its 2016 acquisition of Stemcentrx, Inc. The after-tax net impact of this impairment and the related adjustment to contingent consideration liabilities was $823 million. With this impairment there is no remaining balance on Stemcentrx-related intangible assets. AbbVie continues to focus research and development efforts on other therapies in its oncology portfolio of investigational and marketed medicines.

At the International Congress of Parkinson’s Disease and Movement Disorders, AbbVie presented data from 22 abstracts in Parkinson’s disease (PD) and other neurodegenerative disorders. Final data from the Phase 1b study evaluating the safety and tolerability of the investigational medicine ABBV-951 in patients with advanced PD demonstrated that ABBV-951 is safe and tolerable when delivered via 24-hour continuous subcutaneous infusion for 28 days and support future investigations of ABBV-951 as a potentially new treatment option for PD patients.

AbbVie and Allergan continue to cooperate fully with regulators regarding AbbVie’s proposed acquisition of Allergan and both companies received a Request for Additional Information (Second Request) from the Federal Trade Commission. Additionally, Allergan shareholders voted to approve the proposed acquisition with more than 99 percent of the votes cast at both a special court-ordered meeting of shareholders and at an extraordinary general meeting of shareholders in favor of the transaction. AbbVie and Allergan continue to expect to close the transaction in early 2020.

Full-Year 2019 Outlook

AbbVie is updating its GAAP diluted EPS guidance for the full-year 2019 from $5.69 to $5.79 to $5.08 to $5.10, representing growth of 39.1 percent at the midpoint, inclusive of a non-cash charge for SKYRIZI contingent consideration following regulatory approvals in the second quarter and a third-quarter impairment charge related to intangible assets acquired as part of the 2016 acquisition of Stemcentrx, Inc. AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2019 from $8.82 to $8.92 to $8.90 to $8.92, representing growth of 12.6 percent at the midpoint. The company’s 2019 adjusted diluted EPS guidance excludes $3.82 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

Company Declares Dividend Increase of 10.3 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash
dividend from $1.07 per share to $1.18 per share beginning with the dividend payable on February 14, 2020 to
shareholders of record as of January 15, 2020. This reflects an increase of approximately 10.3 percent,
continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the
company’s inception in 2013, AbbVie has increased its quarterly dividend by 195 percent. AbbVie is a member of
the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least
25 consecutive years.

Statements Required by the Irish Takeover Rules

The directors of AbbVie accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors of AbbVie (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1% or more of any class of relevant securities of AbbVie Inc. may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our third-quarter performance. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results

Financial results for 2019 and 2018 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie’s management believes non-GAAP financial measures provide useful information to investors regarding AbbVie’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company’s 2019 financial guidance is also being provided on both a reported and a non-GAAP basis.

On November 1, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended September 30, 2019 (Press release, ImmunoGen, NOV 1, 2019, View Source [SID1234550171]).

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"The FORWARD I analyses presented at ESMO (Free ESMO Whitepaper) have provided us with valuable insights into the patients who benefit most from mirvetuximab," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We have since met with FDA to review these data and the design of MIRASOL, the Phase 3 study of mirvetuximab for platinum-resistant ovarian cancer patients whose tumors express high levels of folate receptor alpha. We anticipate enrolling our first patient before year-end and, on the strength of the data we have generated in the program, believe we have increased the likelihood of a positive outcome with this next study."

Enyedy added, "IMGN632 continues to make encouraging progress in the clinic, with the initiation of combination studies in relapsed/refractory AML patients and monotherapy expansion into relapsed ALL and MRD+ AML patients following frontline induction therapy. We exit the year with significant momentum across our portfolio with an oral presentation for IMGN632 at ASH (Free ASH Whitepaper), ongoing studies for mirvetuximab combination regimens, advances in our early-stage pipeline, and a strong financial position to execute against our strategic priorities."

RECENT PROGRESS

Presented full data and additional exploratory analyses from the Phase 3 FORWARD I study evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Presented initial safety and overall response data from the Phase 1b FORWARD II triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) in patients with recurrent, platinum-sensitive ovarian cancer at ESMO (Free ESMO Whitepaper).
Met with the United States Food and Drug Administration (FDA) to review the design of MIRASOL, the Phase 3 study evaluating mirvetuximab as monotherapy for women with FRα-high, platinum-resistant ovarian cancer.
Completed enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in "platinum agnostic" ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
For IMGN632 monotherapy, continued enrollment in the Phase 1 expansion cohorts in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), opened an expansion cohort now enrolling patients with relapsed acute lymphocytic leukemia (ALL), and initiated a study in minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
For IMGN632 combination therapy, initiated studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.
Advanced investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
ANTICIPATED UPCOMING EVENTS

Initiate MIRASOL by year-end.
Present preclinical combination data (poster presentation) and updated clinical monotherapy data (oral presentation) for IMGN632 with additional patients enrolled in AML and BPDCN expansion cohorts at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Continue enrollment in IMGN632 combination and single-agent BPDCN, relapsed AML, MRD+ AML, and relapsed ALL expansion cohorts.
IND filing for IMGC936 in the first half of 2020.
Present initial data from FORWARD II platinum agnostic and updated triplet combination studies in mid-2020.
Transition next generation anti-FRα ADC, IMGN151, to pre-clinical development in mid-2020.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2019 were $13.3 million, compared with $10.9 million for the quarter ended September 30, 2018. Revenues in the third quarter of 2019 included $13.2 million in non-cash royalty revenues, compared with $8.4 million for the third quarter of 2018. Revenues for the prior year period also included $0.7 million of license and milestone fees, inclusive of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals, $0.4 million of research and development (R&D) support fees, and $1.4 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the third quarter of 2019 were $31.2 million, compared with $56.5 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $21.0 million in the third quarter of 2019 compared with $47.2 million for the third quarter of 2018. This decrease was primarily due to: lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel and third-party research expenses and lower facility-related allocations; a decrease in clinical trial expenses in the current period driven by greater activity in the FORWARD I Phase 3 clinical trial during the prior year period; and lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year period. General and administrative expenses in the third quarter of 2019 were $9.2 million, compared to $8.3 million in the third quarter of 2018, primarily due to a higher allocation of facility-related expenses for excess laboratory and office space resulting from the recent restructuring. Operating expenses for the third quarter of 2019 also included a $1.0 million charge related primarily to retention costs resulting from the restructuring, compared to a $0.9 million charge recorded in the third quarter of 2018 related to the decommissioning of the Company’s Norwood facility.

ImmunoGen reported a net loss of $21.8 million, or $0.15 per basic and diluted share, for the third quarter of 2019, compared with a net loss of $46.8 million, or $0.32 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.5 million from 147.2 million in those quarters.

ImmunoGen had $204.5 million in cash and cash equivalents as of September 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $55.8 million for the first nine months of 2019, compared with cash used in operations of $125.1 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.8 million and $4.2 million for the first nine months of 2019 and 2018, respectively.

FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2019 as follows:

revenues between $65 million and $70 million;
operating expenses between $170 million and $175 million; and
cash and cash equivalents at December 31, 2019, between $170 million and $175 million.
Revenue guidance has been updated to reflect recognition of deferred revenue under our Jazz Pharmaceuticals collaboration related to IMGN779, which was discontinued as part of ImmunoGen’s portfolio prioritization exercise in June of this year. ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from MIRASOL, which are expected in the first half of 2022.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 8865657. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On November 1, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2019 under International Financial Reporting Standards (IFRS) (Press release, Dr Reddy’s, NOV 1, 2019, View Source [SID1234550168]).

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Commenting on the results, Co-Chairman and MD, GV Prasad said, "I am pleased with our performance across the businesses and strong cash generation during the quarter. We are progressing well in execution of our strategy and in our transformation journey on quality and efficiency."

All amounts in millions, except EPS All US dollar amounts based on convenience translation rate of I USD = Rs. 70.64

Global Generics (GG)

Revenues from GG segment at Rs. 32.8 billion. Year-on-year growth of 7%, primarily driven by Europe, Emerging Markets and India. Sequentially declined by 1%.

Revenues from North America at Rs. 14.3 billion. Year-on-year revenues remained flat. Sequential decline of 13%, on account of price erosion and lower volumes. Further impact on account of voluntary recall of ranitidine and temporary disruption in supplies due to logistics issues faced during this quarter. We launched eight new products during the quarter, which are Carboprost, Ramelteon, Fosaprepitant, Pregabalin, Vigabatrin, Docetaxel 160mg, Bupropion SR and OTC Guaif / Psuedo.

As of 30th September 2019, cumulatively 99 generic filings are pending for approval with the USFDA (96 ANDAs and 3 NDAs under 505(b)(2) route). Of these 96 ANDAs, 55 are Para IVs out of which we believe 31 have ‘First to File’ status.
Revenues from Europe at Rs. 2.8 billion. Year-on-year growth of 44%, primarily on account of new products and volume traction in base business partly offset by lower realizations. Sequential growth is 15%.
Revenues from India at Rs. 7.5 billion. Year-on-year growth of 9%, driven by new products, improved realizations and volume traction in base business. Sequential growth is 8%.
Revenues from Emerging Markets at Rs. 8.3 billion. Year-on-year growth is 10%. Sequential growth is 13%.
Revenues from Russia at Rs. 4.1 billion. Year-on-year growth of 8%. Growth primarily driven by increase in volumes coupled with better realizations in some of the key molecules.
Revenues from other CIS countries and Romania at Rs. 1.7 billion. Year-on-year growth of 16% largely driven by new products and better realizations in some of the key molecules.
Revenues from Rest of World (RoW) markets at Rs. 2.5 billion. Year-on-year growth of 11%, primarily driven by new products, volume traction partly offset by price erosions in some of the key molecules.
Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 7.1 billion. Year-on-year growth of 18% and sequential growth of 57%. Growth largely driven by increase in volumes from existing products.
Proprietary Products (PP)

Revenues from PP at Rs. 7.4 billion. It includes Rs. 7.2 billion towards license fee for selling US and select territory rights for two of our Neurology brands ZEMBRACE SYMTOUCH (sumatriptan injection) 3 mg and TOSYMRATM (sumatriptan nasal spray) 10 mg, to Upsher-Smith Laboratories, LLC. The costs associated with this transaction are Rs. 328 million.
Income Statement Highlights:

Gross profit margin at 57.5%, improved by ~590 bps sequentially and ~250 bps over that of previous year. Gross profit margin for GG and PSAI business segments are at 55.5% and 24.6% respectively.
gross margin is benefitted due to revenue recognition of the PP Neuro brands
partly impacted by certain one-off’s, including but not restricted to the impact of the voluntary recall of Ranitidine in the US market
adjusted for one-off’s, normalized gross profit margin is ~51.5%
on a normalized base, the year on year decline is primarily on account of price erosion in the US.
SG&A expenses at Rs. 16.8 billion, an increase of 36% on a year-on-year basis and 39% sequentially. This includes an amount of Rs. 3.6 billion recognized as an impairment charge on three product related intangibles (viz., Ramelteon, Tobramycin and Imiquimod). There have been certain additional one-offs including but not restricted to the costs associated with the sale of two neurology brands. Adjusted for the one-offs, the normalized SG&A expenses are lower compared to the previous quarter.
R&D expenses at Rs. 3.7 billion. As % to Revenues- Q2 FY20: 7.6% | Q1 FY 20: 9.4% | Q2 FY19: 10.8%. We continue to focus on building a healthy development pipeline across all our focused markets.
Other operating income at Rs. 135 million compared to Rs. 641 million in Q2 FY19 and Rs. 3,759 million in Q1 FY 20. Previous year includes gain of Rs. 464 million on account of sale of rights relating to Cloderm brand (including its authorized generic) and profit on sale of antibiotic manufacturing facility in Bristol, US. Q1 FY 20 includes Rs. 3,457 million received from Celgene pursuant to an agreement entered towards settlement of any claim the Company or its affiliates may have had for damages under section 8 of the Canadian Patented Medicines (Notice of Compliance) Regulations in regard to the Company’s ANDS for a generic version of REVLIMID brand capsules, (Lenalidomide) pending before Health Canada.
Net Finance income at Rs. 231 million compared to Rs. 625 million in Q2 FY19 and Rs. 393 million in Q1 FY 20. The year-on-year decline is primarily on account of lower foreign exchange gain, partly offset by higher profit on sale of investments during the quarter.
Profit after Tax at Rs. 10.9 billion. The net tax for the quarter is a benefit of Rs. 3.3 billion; due to recognition of deferred tax assets of Rs. 5.2 billion, primarily related to the MAT credit.
Diluted earnings per share is at Rs. 65.8.
Capital expenditure is at Rs. 1.1 billion.
Earnings Call Details (06:30 pm IST, 09:00 am EDT, November 1, 2019)

The Company will host an earnings call to discuss the performance and answer any questions from participants.

Audio conference Participants can dial-in on the numbers below:

Universal Access Number:

+91 22 6280 1219

Secondary number:

+91 22 7115 8120

Local Access number:

+91 70456 71221

(Available all over India)

International Toll Free Number

USA

1 866 746 2133

UK

0 808 101 1573

Singapore

800 101 2045

Hong Kong

800 964 448

Playback of call:

+91 22 7194 5757, +91 22 6663 5757

Conference ID:

31923

Transcript of the event will be available at www.drreddys.com. Playback will be available after the earnings call, till November 8, 2019.

On November 1, 2019 Minomic International Ltd reported that it has entered into a research collaboration agreement with Sienna Cancer Diagnostics Ltd (ASX: SDX) ("Sienna" or "the Company"), a medical technology company developing and commercialising innovative cancer-related tests, to develop a proprietary test for the early detection of pancreatic cancer (Press release, Minomic, NOV 1, 2019, View Source [SID1234550126]).

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This will be the first application of Sienna’s capture technology that was acquired in April 2019. The general capture technology is trademarked as SIEN-NET and the specific exosome capture technology as EXO-NET. Sienna will provide EXO-NET beads which rapidly and specifically capture exosomes (nanoparticles shed from cells into the bloodstream) from blood and other body fluids.

Several independent studies have indicated that exosomes from pancreatic cancer patients contain a protein called glypican-1 (GPC-1). Minomic holds a strong intellectual property position around GPC-1 with four families of patents already completing Patent Cooperation Treaty applications. Based on the data, the companies have agreed to enter into a collaboration to conduct research to determine the feasibility of producing an assay for the accurate screening, diagnosis and prognosis of pancreatic cancer.

About pancreatic cancer

Pancreatic ductal adenocarcinoma (PDAC) is the most lethal cancer in humans, with a five-year survival rate of less than 10%. Cancer Australia estimates that 3,599 new cases of pancreatic cancer will be diagnosed in Australia in 2019[1]. Notably, due to the asymptomatic nature of early-stage pancreatic cancer and the lack of a non-invasive early-stage diagnostic assay, approximately 80–85% of cases at initial diagnosis present with unresectable advanced or metastatic disease. The median survival time for these patients is only 3–14 months[2].

A biomarker assay that can specifically detect asymptomatic premalignant or early malignant tumours and predict the response to treatment would greatly benefit these patients[3]. Minomic and Sienna aim to deliver such an assay through this collaboration.

"Minomic International Ltd is excited to work with Sienna to develop this opportunity to extend the use of our GPC-1 antibody beyond prostate cancer detection", said Minomic’s Chief Executive Officer Dr Brad Walsh.

"We are pleased to have entered into this collaboration with Minomic, and we are very hopeful that it will result in the development of a novel and reliable assay for the detection of pancreatic cancer to add to the company’s pipeline of cancer diagnostic tests. It is a perfect first application for our proprietary biomarker capture technology, SIEN-NET", said Sienna’s Chief Executive Officer, Carl Stubbings.

The companies will share the costs of the proof of concept stage of the development.

_____________________________

[1] View Source

[2] Lu H, Niu F, Liu F, Gao J, Sun Y, Zhao X. Elevated glypican-1 expression is associated with an unfavorable prognosis in pancreatic ductal adenocarcinoma. Cancer Med 2017; 6(6):1181–1191

doi: 10.1002/cam4.1064

[3] Qi Z-H, Xu H-X, Zhang S-R, Xu J-Z, Li S, Gao H-L, Jin W, Wang W-Q, Wu C-T, Ni Q-X, Yu X-J, Liu L.

The significance of liquid biopsy in pancreatic cancer. J Cancer 2018; 9(18): 3417-3426. doi: 10.7150/jca.24591