Aurinia Pharmaceuticals to Release Third Quarter 2021 Financial Results on November 3, 2021

On October 27, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that it will release its third quarter 2021 financial results on Wednesday, November 3, 2021, before the markets open (Press release, Aurinia Pharmaceuticals, OCT 27, 2021, View Source [SID1234592043]). Aurinia’s management team will also host a conference call at 8:30 a.m. ET to discuss the Company’s financial results and provide general operational and business updates .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call and webcast is scheduled for November 3, 2021 8:30 a.m. ET. To participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Data from Phase 1/2a study of RM-1929 Photoimmunotherapy in Patients with Recurrent Head and Neck Squamous Cell Carcinoma was Published in Head and Neck

On October 27, 2021 Rakuten Medical, Inc. (Rakuten Medical) reported that data from a phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (RM-1929-101 study, ClinicalTrials.gov Identifier: NCT02422979) was accepted for publication in Head and Neck and published online on October 9th, 2021 (Press release, Rakuten Medical, OCT 27, 2021, View Source [SID1234592063]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The manuscript describes the design and results of the 2-part study, which was aimed to elucidate the recommended dose, safety, pharmacokinetics, immunogenicity, and preliminary efficacy of RM-1929 photoimmunotherapy in patients with locoregional rHNSCC. Part 1* of the study (dose-escalation) determined the recommended drug dose of RM-1929 to be 640 mg/m2 with a fixed light dose of 50 J/cm2 for superficial tumors and 100 J/cm fiber diffuser length for interstitial tumors.

Among Part 2* participants, 30 patients received RM-1929 photoimmunotherapy, and were included in the safety and treated population. Among Part 2* study participants, 13 (43.3%) patients reported a serious TEAE wherein 3 were considered to be treatment related (tumor pain, oral pain, and airway obstruction). Also, for patients enrolled in Part 2* of the study, the median OS was 9.30 months (95% CI 5.16–16.92 months). Confirmed and unconfirmed objective responses were achieved in 13 (43.3%, 95% CI 25.46%–62.57%) patients, with 4 (13%) patients achieving a complete response (CR) and 9 (30.0%) patients demonstrating a partial response (PR). Disease control [defined as CR, PR, or stable disease (SD)] was observed in 24 (80%, 95% CI 61.43%–92.29%) patients.

The full text article is available at View Source

*Part 1: Phase 1 study part (safety and dose-finding) / Part 2: Phase 2a study part (safety and preliminary anticancer activity; patients were treated with up to 4 cycles of RM-1929 photoimmunotherapy)

**RM-1929 and ASP-1929 are analogous. Extensive physiochemical studies show that they have comparable physical and chemical properties.

Lupin Quarter II FY2022 Results

On October 27, 2021 Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter ending September 30, 2021 (Press release, Lupin, OCT 27, 2021, View Source [SID1234592081]). These unaudited results were taken on record by the Board of Directors at a meeting held today.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Income Statement highlights – Q2 FY2022
Gross Profit was INR 23,769 mn compared to INR 27,094 mn in Q1 FY2022, with margin of 59.4%.
Personnel cost was 18.9% of sales at INR 7,586 mn compared to INR 7,837 mn in Q1 FY2022
Manufacturing and other expenses were 28.5% of sales at INR 11,425 mn compared to INR 10,309 mn in Q1 FY2022
Investment in R&D for the quarter was INR 3,300 mn (8.2% of sales)
EBITDA for Q2 FY2022 includes an adverse impact of ~80bps for one-time costs related to US Specialty Restructuring
During the quarter, the company booked a provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups as well as Impairment expense of INR 7,077 mn for Solosec IP
Balance Sheet highlights
Operating working capital was INR 60,526 mn as on September 30, 2021
Capital Expenditure for the quarter was INR 1,451 mn and was INR 2,508mn for H1 FY2022
Net Debt as on September 30, 2021 stands at INR (-)715 mn
Net Debt-Equity for the company as on September 30, 2021 stands at (-)0.01
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said,"Our sustained efforts to drive growth have helped us cross INR 4,000cr sales this quarter. We remain focused on ramping up our revenues in the U.S. while continuing our robust growth in India. With the restructuring in the U.S., we have significantly scaled down the Specialty burn. We remain committed to our journey of margin improvement through sustainable growth and cost optimization, while ensuring the safety of our people and the highest standards of compliance."

Consolidated Financial Results – Q2 FY2022

*Adjusted for NCE Licensing income of INR 3,734 mn in Q1, Gross Margin in Q1 FY2022 would be 60.5% to sales, EBITDA Margin would be 16.0% to sales and PBT Margin would be 9.8% to sales. Further, on an adjusted basis, sales growth in Q2 FY2022 is 3.6% and EBITDA as well as Adjusted PBT Growth is 1.5%

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 62.7% of sales in Q2 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 29.1% of sales in Q2 FY2021.
Includes one-time costs related to US Specialty Restructuring of INR 326 mn
Includes Provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups
Impairment Expense of INR 7,077 mn for impairment of Solosec IP
Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 62.7% of sales in H1 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 28.1% of sales in H1 FY2021.
Includes one-time costs related to US Specialty Restructuring of INR 326 mn
Includes Provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups
Impairment Expense of INR 7,077 mn for impairment of Solosec IP
Operational Highlights
North America
Lupin’s North America sales for Q2 FY2022 were INR 14,291 mn, up 7.2% compared to INR 13,330 mn in Q1 FY2022, up 2.2% as compared to INR 13,984 mn in Q2 FY2021; accounting for 36% of Lupin’s global sales.

Q2 FY2022 sales were USD 184 mn compared to USD 172 mn in Q1 FY2022 and USD 180 mn in Q2 FY2021

The Company filed 4 ANDAs in the quarter, received 1 ANDA approval from the U.S. FDA, and launched 3 products in the quarter in the U.S. market. The Company now has 165 products in the U.S. generics market.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and US total market by prescriptions (IQVIA MAT September 2021). Lupin is the market leader in 55 products in the U.S. generics market and amongst the Top 3 in 120 of its marketed products (market share by extended units, IQVIA June 2021)

During the quarter, we scaled down the US Specialty operations and have reduced the burn going forward. We also booked one-time costs of INR 326 mn related to US Specialty business.

India

Lupin’s India formulation sales for Q2 FY2022 were INR 15,435 mn, down 5.7% as compared to INR 16,362 mn in Q1 FY2022, up 15.9% as compared to INR 13,323 mn in Q2 FY2021; accounting for 38% of Lupin’s global sales.

India Region Formulations sales grew by 16.0% in the quarter as compared to Q2 FY2021.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2021).

Growth Markets (LATAM and APAC)

Lupin’s Growth Markets registered sales of INR 3,490 mn for Q2 FY2022, up 4.9% compared to INR 3,328 mn in Q1 FY2022, up 19.6% as compared to INR 2,918 mn in Q2 FY2021; accounting for 9% of Lupin’s global sales.

Lupin’s Brazil sales were BRL 48 mn for Q2 FY2022 compared to BRL 63 mn for Q1 FY2022 and BRL 59 mn for Q2 FY2021.

Lupin’s Mexico sales were MXN 172 mn for Q2 FY2022 compared to MXN 163 mn for Q1 FY2022 and MXN 155 mn for Q2 FY2021.

Lupin’s Philippines sales were PHP 643 mn for Q2 FY2022 compared to PHP 362 mn for Q1 FY2022 and PHP 341 mn for Q2 FY2021.

Lupin’s Australia sales were AUD 18.3 mn for Q2 FY2022 compared to AUD 17.1 mn for Q1 FY2022 and AUD 14.4 mn for Q2 FY2021.

Europe, Middle-East and Africa (EMEA)

Lupin’s EMEA sales for Q2 FY2022 were INR 3,484 mn, up 33.3% compared to INR 2,613 mn in Q1 FY2022, up 6.9% compared to INR 3,259 mn in Q2 FY2021; accounting for 9% of Lupin’s global sales.

Lupin’s South Africa sales for Q2 FY2022 were ZAR 357 mn, compared to ZAR 273 mn in Q1 FY2022 and ZAR 304 mn in Q2 FY2021.

Lupin is the 6th largest player in South Africa in the total generics market (IQVIA August 2021).

Lupin’s Germany sales for Q2 FY2022 were EUR 7.9 mn, compared to EUR 7.4 mn in Q1 FY2022 and EUR 8.1 mn in Q2 FY2021.

Global API

Lupin’s Global API sales for Q2 FY2022 were INR 2,678 mn, up 8.9% compared to INR 2,459 mn in Q1 FY2022, down 28.4% as compared to INR 3,739 mn in Q2 FY2021; accounting for 7% of Lupin’s global sales.

Research and Development

Investment in R&D amounted to INR 3,300 mn (8.2% of sales) for Q2 FY2022 as compared to INR 3,737 mn (8.8% of sales) for Q1 FY2022.

Lupin received approval for 1 ANDA from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 444 as of September 30, 2021, with the company having received 292 approvals to date.

The Company now has 51 First-to-File (FTF) filings including 20 exclusive FTF opportunities. Cumulative U.S. DMF filings stand at 202 as of September 30, 2021.

BioNTech to Report Third Quarter Financial Results and Operational Update on November 9, 2021

On October 27, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the third quarter on Tuesday, November 9th, 2021 (Press release, BioNTech, OCT 27, 2021, View Source [SID1234592000]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Pittsburgh Life Sciences Greenhouse Proudly Announces Portfolio Company Cernostics is Being Acquired by Castle Biosciences

On October 27, 2021 Pittsburgh Life Science Greenhouse (PLSG) reported to share that one of its portfolio companies, Cernostics, Inc., is being acquired by Castle Biosciences (Nasdaq: CSTL) (Press release, The Pittsburgh Life Sciences Greenhouse, OCT 27, 2021, View Source [SID1234592019]). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the definitive agreement, Cernostics will become a wholly owned subsidiary of Castle Biosciences. At closing, Castle will pay $30 million in initial consideration to Cernostics security holders, which may consist entirely of cash or $20 million in cash and $10 million in common stock of Castle, at Castle’s sole discretion. The purchase price is subject to customary working capital and other adjustments. Further, up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The transaction is expected to close prior to year-end 2021.

"We are excited about joining forces with Castle, a leader in the precision diagnostics space with a strong history of commercial success," said Mike Hoerres, Chief Executive Officer of Cernostics. "We are grateful for the PLSG’s financial and executive management support of our technology. Cernostics could not have gotten to this point without the type of economic development support the PLSG provides."

"PLSG identified early on the value of the assay and worked diligently to provide the support needed for success," said PLSG CEO Diana Cugliari. "We are so excited that this precision diagnostic will now reach more patients and bring early detection to prevent suffering from esophageal cancer. "

The influx of capital PLSG expects to receive from Cernostics’ acquisition will be reinvested back into the region to support the efforts of other life sciences startup companies, simultaneously cultivating scientific breakthroughs, strengthening our region’s economy, and creating jobs.

"The success of Cernostics once again underscores the mission of PLSG – perpetuating the cycle of life sciences startup companies from inception to commercialization and leveraging that success to grow the next generation of life sciences companies to enrich our region’s economy as well as advance scientific discovery. This is another great economic development success story for the region and for the Commonwealth of Pennsylvania, who have steadfastly supported our efforts," said Ms. Cugliari.

Cernostics’ executive management team and other staff who are based in Pittsburgh are expected to stay with the company, and both laboratory and operations will remain in Pittsburgh.