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