Mannkind Corporation Closes Sale-Leaseback Transaction Generating $102.25 Million in Non-Dilutive Gross Proceeds

On November 9, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported the closing on November 8, 2021, of its previously announced sale-leaseback transaction with an affiliate of Creative Manufacturing Properties (Press release, Mannkind, NOV 9, 2021, View Source [SID1234594842]). The transaction results in $102.25 million in non-dilutive gross proceeds to MannKind. Simultaneous with closing of the purchase and sale agreement, MannKind entered into a 20-year lease agreement with the purchaser, with multiple renewal options available.

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 real property sale includes 263,900 square feet of manufacturing space at 1 Casper Street in Danbury, Conn. (commonly known as Building 1), but does not include MannKind’s research and development facility (commonly known as Building 8). MannKind will continue to be the sole operator of the entire Connecticut facility. This location is where MannKind produces Afrezza (insulin human) Inhalation Powder, the company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States. It is also where MannKind manufactures Tyvaso DPI (inhaled treprostinil) under its collaboration with United Therapeutics.

Greenwich LifeSciences Provides Updated Corporate Presentation and Webcasts

On November 9, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported its updated corporate presentation and recent webcasts (Press release, Greenwich LifeSciences, NOV 9, 2021, View Source [SID1234594841]).

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!

A webcast of the Company’s updated corporate presentation with comments by CEO Snehal Patel is available in the investor section of the Company’s website here.

Mr. Patel commented, "We are very excited to be presenting the combined analysis of our 5 year Phase IIb data from our recently published posters on one timeline, and we expect more upcoming publications. Integrated analysis of efficacy, immune response, and safety data has attracted the interest of large institutions, including large pharma, regional pharma, and biotech institutional investors, whom we are presenting to at investor and international partnering conferences. We have been discussing possible licensing of GP2, new investment banking partners, collaboration in our Phase III clinical trial, commercial manufacturing, expansion of our pipeline, expansion of our clinical trials in Europe, and initiation of additional GP2 Phase II/III trials."

Additional webcasts of Mr. Patel’s participation on a Benzinga cancer panel and a TD Ameritrade interview can be viewed at the links below:

On September 30, 2021, Mr. Patel participated in a live panel discussion at the Benzinga Healthcare Small-Cap Conference entitled: Immuno-Oncology – Harnessing the Human Body’s Power to Battle Cancer. A webcast of the entire panel discussion can be seen here with Mr. Patel speaking at the time points available at these links: 2:15, 18:03, and 34:00.

On July 20, 2021, Mr. Patel appeared as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Bayer-grows-sales-and-earnings-significantly

On November 9, 2021 The Bayer Group reported that registered a significant increase in sales and earnings in the third quarter of 2021 (Press release, Bayer, NOV 9, 2021, View Source [SID1234594840]). "We delivered strong operational performance, with all divisions showing strong growth momentum," said Werner Baumann, Chairman of the Board of Management, on Tuesday when presenting the company’s third-quarter results. Bayer posted substantial growth in the agricultural business, while the Pharmaceuticals Division benefited in particular from large gains for the Eylea ophthalmology drug. Business at the Consumer Health Division was up in all regions and product categories. Bayer has also updated the upgraded outlook for 2021 that it had issued in August.

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!

Group sales in the third quarter of 2021 rose by 14.3 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 9.781 billion euros. There was a positive currency effect of 67 million euros. EBITDA before special items increased by 16.4 percent to 2.089 billion euros, and included a negative currency effect of 44 million euros. EBIT came in at 530 million euros (Q3 2020: minus 9.399 billion euros) after net special charges of 694 million euros (Q3 2020: 10.181 billion euros) that primarily related to restructuring measures at all three divisions. Net income amounted to 85 million euros (Q3 2020: minus 2.744 billion euros), while core earnings per share advanced by 29.6 percent to 1.05 euros, mainly due to the development of business within the Crop Science Division.

Free cash flow increased by 58.0 percent to 1.954 billion euros. Net financial debt as of September 30, 2021, decreased to 33.981 billion euros, down 1.1 percent from June 30, 2021.

Crop Science reports strong sales gains and significant earnings growth

In the agricultural business (Crop Science), sales rose by 25.8 percent (Fx & portfolio adj.) to 3.850 billion euros thanks to a substantial increase in volumes and prices. Growth was particularly strong at Corn Seed & Traits (Fx & portfolio adj. 92.6 percent), driven by gains in North America due to lower product returns and the later receipt of license revenues. As expected, these license revenues were recorded in the third quarter this year as opposed to the second quarter as in 2020. Sales also advanced in Latin America due to the launch of the new VTPro4 trait for improved pest control as well as higher volumes and prices. Soybean Seed & Traits also registered strong growth (Fx & portfolio adj. 58.0 percent), driven by gains in North America – due to lower product returns and higher license revenues – and in Latin America as a result of higher prices and volumes. Herbicides also posted a substantial increase in sales (Fx & portfolio adj. 15.2 percent), with the business recording encouraging gains in North America and Europe/Middle East/Africa, mainly due to an increase in prices for glyphosate-based products and higher volumes.

EBITDA before special items at Crop Science rose to 471 million euros (Q3 2020: minus 34 million euros), resulting in a margin of 12.2 percent. The improvement in earnings was mainly attributable to higher prices and volumes, an increase in license revenues, and contributions from ongoing efficiency programs. By contrast, earnings were diminished in particular by an increase in the cost of goods sold.

Pharmaceuticals reports higher sales – new products provide boost

Sales of prescription medicines (Pharmaceuticals) rose by 7.1 percent (Fx & portfolio adj.) to 4.539 billion euros. The division’s ophthalmology business was able to grow market share and continued to recover following the COVID-19 restrictions, especially in Europe. As a result, sales of Eylea advanced by 19.0 percent (Fx & portfolio adj.). Sales of the oral anticoagulant Xarelto increased by 4.3 percent (Fx & portfolio adj.), with substantial volume growth in Russia and Germany in particular offsetting a price-related decline in China. Sales of Adalat, one of the company’s products for the treatment of heart disease, rose by 24.2 percent (Fx & portfolio adj.) thanks to higher volumes in China. An increase in volumes in the United States resulted in sales gains for the pulmonary hypertension product Adempas (Fx & portfolio adj. 21.0 percent). Sales of Nubeqa rose significantly, driven by the cancer drug’s successful launch in the United States, which is currently ongoing. In addition, Bayer initiated the market launch of Kerendia, its product for the treatment of patients with chronic kidney disease and type 2 diabetes, in the United States. By contrast, sales of the cancer drug Nexavar declined against the prior-year period (Fx & portfolio adj. 27.8 percent), particularly in China, where business was negatively impacted by strong competition and modified tender procedures for various classes of active ingredients.

EBITDA before special items at Pharmaceuticals decreased by 9.8 percent to 1.366 billion euros, resulting in a margin of 30.1 percent. Earnings were diminished by an increase in marketing costs, which was largely attributable to the launch of Kerendia and Nubeqa, and by a rise in research and development expenses, which was partly related to the division’s cell and gene therapy unit.

Consumer Health continues to grow and increases earnings

Sales of self-care products (Consumer Health) came in at 1.346 billion euros, up 10.9 percent (Fx & portfolio adj.) against a very strong prior-year quarter, with growth in all regions and categories. Business primarily benefited from continued high demand in Nutritionals, which saw sales rise 20.1 percent (Fx & portfolio adj.), and the launch of innovative products in all categories throughout the year. The Pain & Cardio category also registered particularly strong growth of 17.4 percent (Fx & portfolio adj.)

EBITDA before special items at Consumer Health increased by 2.3 percent to 308 million euros, resulting in a margin of 22.9 percent. The growth in earnings was driven by the division’s strong business performance and continuous cost management efforts. This was partially offset by investments associated with the launch of innovative products and by inflation-related increases in costs. 

Updated outlook

Following the very good business performance in the third quarter, Bayer has revised the upgraded outlook for 2021 that it issued in August. On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2020), the company continues to expect sales to come in at approximately 44 billion euros. This now corresponds to currency- and portfolio-adjusted growth of approximately 7 percent (previously: approximately 6 percent). The forecast for the currency-adjusted EBITDA margin before special items remains unchanged at around 26 percent. Core earnings per share are now expected to come in at approximately 6.50 euros to 6.70 euros after adjusting for currency effects (previously: approximately 6.40 euros to 6.60 euros). Free cash flow is now anticipated to amount to between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros) as a portion of the settlement payments for the glyphosate litigations are now expected to be made in 2022 instead of 2021. In addition, Bayer is now anticipating net financial debt of around 35.5 billion euros (previously: around 36 billion euros) at the end of the year after adjusting for currency effects.

Based on the closing exchange rates on September 30, 2021, the company continues to expect full-year sales to come in at approximately 43 billion euros. This now corresponds to currency- and portfolio-adjusted sales growth of approximately 7 percent (previously: approximately 6 percent). The EBITDA margin before special items is now expected to amount to approximately 25.5 percent (previously: approximately 25 percent). The company is now anticipating core earnings per share of approximately 6.10 euros to 6.30 euros (previously: approximately 6.00 euros to 6.20 euros). Free cash flow is now expected to come in at between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros). The company’s forecast for net financial debt remains unchanged at around 35 billion euros.

"New technologies vitally important for health and nutrition"

"Our third-quarter performance shows that we are very much on the right track – both in terms of operational development and the market launch of new products," said Baumann, underlining Bayer’s strength in delivering innovations. "We have aligned our corporate strategy and our innovation potential toward health and nutrition, which are areas of systemic importance. In doing so, we are looking to help solve a question of fundamental importance: How do we feed and satisfy the health needs of a growing population in the face of climate change?"

New technologies are vitally important in this respect, he explained. Together with its partners, the company is working on numerous projects involving technologies that can really make a difference for society. For example, Bayer is working on two novel therapeutic approaches for Parkinson’s, a nervous system disorder for which there is currently no cure. Via its Leaps unit, the company has also invested in three biotech start-ups that are harnessing various technologies in their research on microbial engineering, potentially paving the way for more crops to fertilize themselves in the future. This would be great news for the climate, as it would enable farmers to bypass nitrogen fertilizers, which are used to grow around 40 percent of the world’s food but also account for roughly 4 percent of all greenhouse gas emissions worldwide.

Sustainability: Three-fold increase in volume of renewable energy sourced via supply agreements

Bayer is also working intensively on its ambitious sustainability targets, with the company committed to becoming carbon neutral in its own production operations by 2030. In addition to investing in more energy-efficient facilities and building technologies, it is also extensively harnessing renewable energy sources. As of the end of the third quarter, Bayer has this year concluded agreements covering around 400,000 megawatt-hours of green energy, representing a three-fold increase in volume.

Reinforcing its commitment to improve access to family planning, especially in low- and middle-income countries, the company recently initiated the construction of a new production site in Costa Rica and the expansion of an existing facility in Finland. Both sites are set to produce long-acting reversible contraceptives in the future. These investments are a milestone as the company works toward meeting its sustainability target of providing 100 million women with access to modern family planning by 2030.

PureTech Announces Participation at the Jefferies London Healthcare Conference

On November 9, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that Bharatt Chowrira, Ph.D., J.D., President and Chief of Business and Strategy, and George Farmer, Ph.D., Chief Financial Officer, will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021, at 7:20 AM EST (Press release, PureTech Health, NOV 9, 2021, View Source [SID1234594839]). A webcast of the presentation will be available at View Source

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!

Additionally, the Company reported PureTech Level Cash and Cash Equivalents of $387.3 million and Consolidated Cash and cash equivalents of $441.0 million as of September 30, 2021.3 PureTech’s Founded Entities are also well-capitalized, having raised over $1.6 billion since July 2018, 96% of which came from third-party investors.4

Non-IFRS Financial Measures

PureTech Level Cash and Cash Equivalents is an alternative performance measure which is adjusted and constitutes a non-IFRS measure. We believe that these non-IFRS performance measures, when provided in combination with IFRS measures, will provide investors, analysts and other stakeholders with helpful complementary information to better understand our financial position from period to period. The measures are also used by management for planning and reporting purposes. The measures are not substitutable for IFRS measures and should not be considered superior to measures presented in accordance with IFRS.

PureTech Level Cash and Cash Equivalents is defined as cash and cash equivalents held at PureTech Health plc and its wholly-owned subsidiaries only. Please see below for a reconciliation to Consolidated Cash and cash equivalents, which is the most directly comparable measure calculated in accordance with IFRS.

PureTech Level Cash and Cash Equivalents

1. PureTech Level Cash and Cash equivalents as of September 30, 2021 represent cash and cash equivalents held at PureTech Health plc and its wholly-owned subsidiaries only. Please see the section captioned "Non-IFRS Financial Measures" included in this release for additional information.

2.Consolidated Cash and cash equivalents as of September 30, 2021 represent cash and cash equivalents for PureTech Health plc in accordance with International Financial Reporting Standards (IFRS). Please see the section captioned "Non-IFRS Financial Measures" included in this release for additional information.

3.These figures are unaudited and do not present all information necessary for an understanding of the Company’s financial condition as of September 30, 2021.

4. Funding figure includes private equity financings, loans and promissory notes, public offerings, or grant awards. Funding figure excludes future milestone considerations received in conjunction with partnerships and collaborations such as with, Boehringer Ingelheim, Imbrium Therapeutics L.P., Shionogi & Co Ltd, or Eli Lilly.

ERYTECH to Present at the 12th Annual Jefferies Global London Healthcare Conference

On November 9, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that its CEO, Gil Beyen, will participate in a fireside chat at the 12th Annual Jefferies London Healthcare Conference and invites investors to participate in one-on-one meetings both in-person on Tuesday and Wednesday, November 16th/17th or virtually on Thursday and Friday, November 18th/19th (Press release, ERYtech Pharma, NOV 9, 2021, View Source [SID1234594838]).

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!