On July 29, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company has scheduled the release of its second quarter 2020 financial results after the market closes on Wednesday, August 5, 2020 (Press release, Sangamo Therapeutics, JUL 29, 2020, View Source [SID1234562586]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5667347. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5667347.

On July 29, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY) reported its consolidated financial results for the quarter ended June 30, 2020 (Press release, Dr Reddy’s, JUL 29, 2020, View Source [SID1234562550]). 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-19 Update
In the current challenging times due to the COVID-19 pandemic, we are undertaking reasonable precautions to ensure the health and safety of our employees, including adhering to the social distancing norms, sanitization of our premises, usage of masks, gloves and other protective wears.

Our operations have continued without much impact. We continued our engagement with doctors through digital channels, ensured regular supplies of our products to meet with the market demand and continued our R&D activities including few projects pertaining to COVID-19.

While the sales volume were impacted in some of our markets due to lower prescriptions generated and fall in patient footfalls in pharmacies / clinics due to Covid-19, the pricing environment was relatively stable, new products launches continued and depreciation of rupee against the US dollar and Euro supported the business.

Revenue Analysis
Global Generics (GG)
Revenues from GG segment at Rs. 35.1 billion:
 Year-on-year growth of 6% driven primarily by Europe and Emerging Markets. This was offset partially by decline in India. The overall growth was on account of volume traction in the base business, new product launches and aided by favorable forex rates, though offset partially due to price erosion.
 Sequential quarter decline of 4%, which is attributable to lower volumes across markets.

North America
Revenues from North America at Rs. 17.3 billion:
 Year-on-year growth of 6%, driven by contribution from new products launched and aided by a favorable forex rate, which was partially offset by price erosion.
 Sequential decline of 4%, on account of lower sales of certain key molecules.
 We launched six new products (Fenofibrate Tablets, Nitroglycerin Patch, Amphetamine Sulfate Tablets, Desmopressin Acetate Ampules, Colchicine Tablets and Abiraterone Acetate Tablets)
 We filed five new ANDAs during the quarter. As of 30th June 2020, cumulatively 101 generic filings are pending for approval with the USFDA (99 ANDAs and 2 NDAs under 505(b)(2) route). Of the 99 ANDAs, 54 are Para IVs and we believe 28 have ‘First to File’ status.

Emerging Markets
Revenues from Emerging Markets at Rs. 8.0 billion. Year-on-year growth of 9%. Sequential decline of 1%:
 Revenues from Russia at Rs. 3.3 billion. Year-on-year decline of 17% and sequential decline of 16%. Decline primarily on account of lower volumes due to lower prescriptions generated and fall in patient footfalls in pharmacies / clinics due to Covid-19.
 Revenues from other CIS countries and Romania market at Rs. 1.4 billion. Year-on-year growth of 15% driven by higher volumes and new product launches. Sequential decline of 22% on account of lower volumes.
 Revenues from Rest of World (RoW) territories at Rs. 3.3 billion. Year-on-year growth of 56% & sequential growth of 41%, primarily driven by new products and volume traction in base business. The growth was offset partially due to price erosion in some molecules

India
Revenues from India at Rs. 6.3 billion:
 Year-on-year decline of 10% and sequential decline of 8%. The decline was on account of lower sales volume due to lower prescriptions generated and fall in patient footfalls in pharmacies / clinics due to Covid-19.
 We launched four new brands during the period.
 We completed the acquisition of select business from Wockhardt including the manufacturing plant located in Baddi, Himachal Pradesh in the quarter.

Europe
Revenues from Europe at Rs. 3.6 billion:
 Year-on-year growth of 48%, on account of new product launches and volume traction across markets.
 Sequential growth of 3%, aided by contribution by new products launched and favorable forex, offset partially by lower volumes.

Pharmaceutical Services and Active Ingredients (PSAI)
Revenues from PSAI at Rs. 8.6 billion:
 Year-on-year growth of 88% and sequential growth of 19% on account of higher volumes of certain products, increase in new product sales and favorable forex.
 During the quarter we filed DMF for one product in the US. Proprietary Products (PP) Revenues from PP at Rs. 56 million:
 Year-on-year decline of 80% due to absence of the Neurology franchise products (the US and select territory rights of which were sold in the previous year).

Income Statement Highlights:
 Gross profit margin at 56.0%:
– Increased by ~430 bps over previous year and by ~450 bps sequentially, primarily on account of a favorable product mix and forex benefit.
– Gross profit margin for GG and PSAI business segments are at 61.4% and 33.4% respectively.

 SG&A expenses at Rs. 12.8 billion, increased by 6% on a year-on-year basis and by 5% sequentially. The increase was primarily attributable to higher freight cost due to shortage of carriers for shipping the goods from India to other countries due to COVID-19 related disruptions.
 R&D expenses at Rs. 4.0 billion. As % to revenues- Q1 FY21: 9.0% | Q4 FY 20: 9.5% | Q1 FY20: 9.4%. Our focus continues on building complex generics, bio-similars and differentiated products pipeline. We are also undertaking development of a few projects pertaining to COVID-19 related drugs.

 Other operating income at Rs. 118 million compared to Rs. 3.8 billion in Q1 FY20. Previous year included Rs. 3.5 billion 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. 605 million compared to Rs. 393 million in Q1 FY20. The increase is primarily on account of higher foreign exchange gain as compared to the previous year.
 Profit before Tax at Rs. 8.8 billion, increased by 3% year-on-year and by 23% sequentially. Adjusted for the Rs. 3.5 billion received from Celgene last year, the year-on-year growth is at 74%.
 Profit after Tax at Rs. 5.8 billion. The effective tax rate is around 34% for the quarter. The higher tax rate was primarily due to discontinuation of weighted deduction on R&D and completion of tax holiday for one of our plants.
 Diluted earnings per share is at Rs. 34.86

Other Highlights:
 Capital expenditure is at Rs. 1.5 billion.
 Free cash-flow generated during the quarter stood at Rs. 9.3 billion (before acquisition related payout to Wockhardt of Rs. 15 billion).
 Net debt of the company is at Rs. 3.4 billion as on June 30, 2020. Consequently, net debt to equity ratio is 0.02.

On July 29, 2020 Sanofi reported that it has pulled out of a pediatric pentavalent vaccine collaboration with Daiichi Sankyo in Japan (Press release, FierceBiotech, JUL 29, 2020, https://www.fiercebiotech.com/biotech/sanofi-pulls-out-late-phase-daiichi-vaccine-collaboration [SID1234562549]). The action, which Sanofi disclosed (PDF) alongside other pipeline updates, follows a multiyear effort to get phase 3 data on the vaccine candidate.

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Japan has lagged other parts of the world in adopting pentavalent vaccines that prevent pertussis, diphtheria, tetanus, poliomyelitis and Hib, choosing instead to give tetravalent and single antigen shots concomitantly. Sanofi was working with Daiichi to change that, but disclosed in its second-quarter results that it has "decided not to pursue the collaboration."

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The action follows years in which the targeted filing date for the vaccine has slipped steadily. A phase 3 study got underway in Japan in 2014. By 2017, Sanofi was planning to file for approval in 2020. The target slipped to 2021 the following year. Earlier this year, Sanofi moved the vaccine into its "2023 and beyond" group of planned filings. Now, Sanofi has dropped the filing plan altogether.

Sanofi also used the pipeline update to confirm a change in its collaboration with Denali. As Denali disclosed last month, the partners have dropped their phase 1 RIPK1 inhibitor SAR 443060 in favor of a backup compound.

Denali said the decision reflected "emerging evidence that higher levels of target inhibition may be required for maximizing efficacy, and challenges to achieving higher doses imposed by molecule-specific toxicity findings." The now-dropped drug went through two phase 1b studies in Alzheimer’s disease and amyotrophic lateral sclerosis, plus chronic toxicity studies in cynomolgus monkeys.

Elsewhere, the combination of Sarclisa and Libtayo was the only phase 2 removal disclosed by Sanofi in the update. Sanofi decided not to pursue the combination in multiple myeloma after finding that adding PD-1 inhibitor Libtayo to anti-CD38 antibody Sarclisa yielded "insufficient additional efficacy" over the latter drug as a monotherapy.

On July 29, 2020 Amgen reported a bispecific drug it picked up in a $1.7 billion biobucks deal with Xencor (Press release, Amgen, JUL 29, 2020, View Source [SID1234562548]).

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In its second-quarter results, the biopharma said: "Phase 1 development of AMG 424, a CD38-CD3 XmAb antibody has been stopped, with rights reverting to Xencor."

Amgen nabbed the preclinical asset back in 2015 as part of an early-stage, bispecific six-drug development deal with Xencor. Under the deal, Amgen paid just $45 million upfront to use its R&D tech on some preclinical antibodies designed to harness the body’s natural defenses.

The pact was worth up to $1.7 billion in biobucks.
Xencor had been the biotech partner of choice for a number of Big Pharmas but was beginning to fall out of favor. In January last year, Novartis also returned the rights to a bispecific antibody it had licensed as part of a 2016 deal worth up to $2.41 billion.

A few months down the line, and the biotech was hit again after a second asset from that deal, in development for acute myeloid leukemia, hit a snag in the form of a partial clinical hold from the FDA. This came after a failed phase 2 test in lupus for the company in 2018.

But things had started to turn around: After working with Xencor to change the study protocol, the FDA lifted the partial clinical hold April 30.

And although Xencor lost Novartis as a partner on one of its programs, it picked up a new partner, licensing its preclinical-stage IL-15 cytokine therapeutics to Genentech for $120 million upfront in February last year.

Since then, Xencor has inked an R&D deal with Astellas and started phase 1 studies for two more bispecific antibodies in advanced solid tumors: XmAb2314, which targets PD-1 and ICOS, and XmAb22841, which targets CTLA-4 and LAG-3. The latter treatment is being tested in combination with Keytruda in an effort to block three checkpoints at once.

But the Amgen cull was still a hard hit for the biotech in the short term, with its shares off nearly 5% after-hours Tuesday on the news.

Meanwhile, one of the most keenly watched cancer drugs in development, KRAS drug AMG 510 (now known as sotorasib) is still on track to deliver data from a potentially pivotal phase 2 monotherapy study in patients with advanced non-small cell lung cancer (NSCLC) in the coming months, despite ongoing pandemic disruptions to trials.

Amgen also noted its phase 3 CodeBreaK 200 study comparing sotorasib to docetaxel is also now "enrolling patients with advanced NSCLC," while it has six phase 1 combination cohorts also enrolling.

Sales for Amgen grew 6% to $6.2 billion for the second quarter.

On July 29, 2020 Inhibrx reported that it has set a preliminary $100 million IPO goal, up by about one-third from the target it set last year. The company has applied for a Nasdaq listing under the stock symbol "INBX (Press release, Inhibrx, JUL 29, 2020, View Source [SID1234562541])."

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As of late June, every biotech IPO this year had priced at or above the midpoint of its price range or offered more shares than it initially planned, according to research firm Renaissance Capital.

Inhibrx has four investigational drugs all in Phase 1 testing; three for cancers and another for a rare genetic disease called alpha-1 antitrypsin (AAT) deficiency. The drug candidates deploy single-domain antibodies, antibody fragments that the company believes may best other antibody and biologic therapies on safety and efficacy because of their smaller size and "highly modular" properties.

The company’s most advanced candidate, INBRX-109, is under evaluation in patients with chondrosarcoma and mesothelioma, two rare and aggressive cancers. The drug is designed to stimulate DR5, a member of the tumor necrosis factor (TNF) receptor superfamily, which plays a role in immune response.

Also in early testing is INBRX-106, which is intended to stimulate OX40, another TNF receptor superfamily member, in locally advanced or metastatic solid tumors, and INBRX‑105, which is designed to both inhibit the protein PD-L1 and to stimulate 4-1BB, a receptor found on T cells, to enhance the anti-tumor immune response. Based on preclinical data, Inhibrx says that both drug candidates could be used to complement or replace the use of a class of approved cancer immunotherapies called checkpoint inhibitors.

A Phase 1 study for its AAT program was paused due to the COVID-19 pandemic, but the company aims to resume enrollment in the fourth quarter. Italy’s Chiesi Group last year acquired the option to exclusively license global rights to the AAT program, excluding the US and Canada.

The company anticipates reporting initial data from INBRX-109 and INBRX-106 by year’s end, and additional data from all four programs during 2021.

With its IPO cash the company plans to advance these potential treatments through the ongoing trials and to scale up its commercial manufacturing activities. Currently the biotech’s largest outside shareholders are Lilly Asia Ventures, which owns nearly 10 percent of the company and RA Capital, which holds 8.4 percent, according to the IPO paperwork.

Since raising $40 million last year from Viking Global Investors in the form of a convertible note, Inhibrx has raised $15 million more in a similar financing, from Viking and other investors, according to its prospectus.

The company was founded in 2010 by Mark Lappe, Brendan Eckelman, and Quinn Deveraux, the company’s CEO, chief scientific officer, and head of early research, respectively.