On February 25, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the following investor conferences in March (Press release, Coherus Biosciences, FEB 25, 2021, View Source [SID1234575629]).

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!

41st Annual Cowen Healthcare Conference on Monday, March 1 at 4 p.m. ET
Barclays Global Healthcare Conference on Tuesday, March 9 at 1:15 p.m. ET
The audio portion of the presentation will be available on the investors’ page of the Coherus BioSciences website at View Source

On February 25, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that Dr. Amit Kumar, Anixa’s Chief Executive Officer, will present at the virtual H.C. Wainwright Global Life Sciences Conference being held March 9-10, 2021 (Press release, Anixa Biosciences, FEB 25, 2021, View Source [SID1234575628]).

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!

During the presentation, Dr. Kumar will provide an overview of Anixa’s business and an update on each of the Company’s programs. Company management will also be available to participate in online one-on-one meetings with conference attendees.

Details of Anixa’s presentation are as follows:

Event: H.C. Wainwright Global Life Sciences Conference

Date & Time: On demand, beginning 7:00 a.m. ET, Tuesday, March 9, 2021

Webcast link: View Source

An archive of the webcast will remain available for 90 days after the event.

On February 25, 2021 MannKind Corporation (NASDAQ:MNKD) reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Mannkind, FEB 25, 2021, View Source [SID1234575627]).

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!

"Our fourth quarter produced exceptional results, with $10.1 million in Afrezza net revenue and positive clinical data for Tyvaso DPI from the BREEZE study conducted by United Therapeutics," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "UT also announced their plan to submit a new drug application for Tyvaso DPI to the FDA in April 2021. During the fourth quarter, we solidified our new direction with the acquisition of QrumPharma, which added a nebulized version of clofazimine to our pipeline of therapies for orphan lung diseases, and we entered into a collaboration agreement with Vertice for the co-promotion of Thyquidity, which is indicated for hyperthyroidism and is expected to expand our reach into endocrine diseases."

Fourth Quarter 2020 Results

Total revenues were $18.4 million for the fourth quarter of 2020, reflecting Afrezza net revenue of $10.1 million and collaborations and services revenue of $8.4 million. Afrezza net revenue increased 30% compared to $7.8 million in the fourth quarter of 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges and more favorable gross-to-net deductions. Collaborations and services revenue increased $0.2 million compared to the fourth quarter of 2019.

Afrezza gross profit for the fourth quarter of 2020 was $6.4 million compared to $3.1 million in the same period of 2019, an increase of $3.3 million, or 105%, that was driven by a combination of increased Afrezza revenue and a reduction in cost of goods sold.

In-process research and development expense for the fourth quarter of 2020 was $13.2 million, reflecting the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs. The acquisition of QrumPharma was accounted for as an asset acquisition and expensed on the date of acquisition as substantially all of the fair value of the assets acquired was concentrated in a single asset that consisted of in-process research and development in a pre-clinical development state.

Research and development expenses for the fourth quarter of 2020 were $1.5 million compared to $2.0 million for the fourth quarter of 2019. This decrease was mainly related to lower clinical trial spending.

Selling, general and administrative expenses for the fourth quarter of 2020 were $17.1 million compared to $15.7 million for the fourth quarter of 2019. This increase of $1.4 million, or 9%, was primarily attributable to a $1.2 million increase in personnel costs related to the expansion of our sales and medical field force.

During the fourth quarter of 2020, loss on foreign currency translation for insulin purchase commitments, which are denominated in Euros, was $4.0 million compared to $2.6 million for the fourth quarter of 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the fourth quarter of 2020 was $2.4 million compared to $2.3 million for the fourth quarter of 2019.

The net loss for the fourth quarter of 2020 was $26.4 million, or $0.11 per share, compared to $14.3 million in the fourth quarter of 2019, or $0.07 per share. The increase in the net loss of $12.1 million was primarily due to the write-off of in-process research and development related to the acquisition of QrumPharma. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the fourth quarter of 2020 was $13.2 million, or $0.06 per share.

Twelve Months Ended December 31, 2020

Total revenues were $65.1 million for the year ended December 31, 2020, reflecting Afrezza net revenue of $32.3 million and collaborations and services revenue of $32.8 million. Afrezza net revenue increased 28% compared to $25.3 million for the year ended December 31, 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges, a price increase and more favorable gross-to-net deductions, all of which was partially offset by a reduction in sales to Biomm (Brazil). Collaborations and services revenue decreased $4.9 million compared to the full year ended December 31, 2019, primarily driven by a $5.8 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019.

Afrezza gross profit was $17.2 million for the year ended December 31, 2020, an increase of $12.0 million, or 230%, compared to a gross profit of $5.2 million in the same period in 2019, primarily due higher commercial product sales combined with a reduction in cost of goods sold.

In-process research and development expense for the year ended December 31, 2020 was $13.2 million, reflecting the research and development acquired and expensed from the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs.

Research and development expenses for the year ended December 31, 2020 were $6.2 million compared to $6.9 million for the year ended December 31, 2019. This decrease of $0.7 million, or 9%, was primarily attributable to lower clinical trial spending.

Selling, general and administrative expenses for the year ended December 31, 2020 were $59.0 million compared to $74.7 million for the year ended December 31, 2019. This decrease of $15.6 million, or 21%, was primarily attributable a $9.3 million decrease in costs for television advertising for Afrezza, a $4.1 million decrease in promotional and marketing activities in response to the COVID-19 pandemic and a $2.5 million decrease in professional fees.

An impairment of $1.9 million was recognized for the year ended December 31, 2020 on a commitment asset and debt issuance costs related to future funding commitments of the MidCap Credit Facility. There were no asset impairments for the year ended December 31, 2019.

For the year ended December 31, 2020, foreign currency translation for insulin purchase commitments, which are denominated in Euros, resulted in a loss of $8.0 million compared to a gain of $1.9 million for the year ended December 31, 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

Interest expense on debt for the year ended December 31, 2020 was $9.5 million compared to $10.9 million for the year ended December 31, 2019. This $1.4 million decrease was primarily attributable to a $3.4 million milestone obligation to Deerfield that was achieved in the third quarter of 2019 and a decrease of $0.8 million of interest expense related to the Deerfield Credit Facility, which was extinguished in the third quarter of 2019. This decrease was partially offset by an increase in interest expense from the MidCap Credit Facility of $2.3 million and an increase in interest expense from our Mann Group promissory notes of $0.6 million in 2020.

The net loss for the year ended December 31, 2020 was $57.2 million, or $0.26 per share, compared to $51.9 million net loss for the year ended December 31, 2019, or $0.27 per share. The higher net loss was mainly attributable to the write-off of in-process research and development related to the acquisition of QrumPharma and a loss on foreign currency translation related to insulin purchase commitments denominated in Euros, offset by a decrease in selling, general and administrative expenses. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the year ended December 31, 2020 was $44.0 million, or $0.20 per share.

Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2020 was $67.2 million compared to $50.2 million at December 31, 2019.

Debt Reductions Subsequent to December 31, 2020

Pursuant to the terms of the senior convertible notes, the Company forced the conversion of all $5.0 million in principal of such notes into 1,666,667 shares of the Company’s common stock.

In addition, the Mann Group converted $9.6 million of principal and $0.4 million of accrued interest on its convertible promissory note into 4.0 million shares of the Company’s common stock. As of the date hereof, $53.4 million in principal remains outstanding under the promissory notes held by the Mann Group ($18.4 of which is convertible).

Sale-Leaseback of the Danbury Manufacturing Facility

Subsequent to December 31, 2020, the Company entered into a non-binding letter of intent ("LOI") with a third party to sell and lease back a portion of the Company’s Danbury manufacturing facility and administrative offices. The terms of the LOI include a sales price of approximately $95 million – $105 million, a lease term of 20 years with four 5-year renewal options, and annual rent of approximately $10 million – $11 million at the beginning of the lease. If the transaction is completed, the Company intends to use the proceeds for general corporate purposes, and may also pay down a portion of its senior secured debt. The completion of the transactions contemplated by the LOI is subject to certain conditions, including the negotiation of satisfactory definitive agreements and satisfactory results of the buyer’s inspections and other investigations, all of which are anticipated to be completed during the first quarter of 2021. However, there can be no assurances that this proposed transaction will be completed in the timeframe or on the principal terms set forth above, or at all.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events. A replay will be available on MannKind’s website for 14 days.

On February 25, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the fourth quarter and full-year of 2020 (Press release, Pacira Pharmaceuticals, FEB 25, 2021, View Source;991.htm [SID1234575626]).

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!

"Our nation’s opioid crisis has escalated under the shadow of the COVID-19 pandemic, as isolation and lack of access to healthcare has exacerbated mental health challenges, particularly addiction. I am delighted to report that EXPAREL-based protocols are expanding opioid-sparing pain management for a variety of procedures where historically poor postsurgical pain management fueled such addictions. Despite these challenging times, we have quickly adapted to a virtual world and delivered record revenues for 2020," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Looking ahead to the balance of the year, we remain steadfast in our commitment to providing an opioid alternative to as many patients as possible and redefining the role of opioids as a rescue medication while enabling the migration to hospital outpatient and ambulatory surgery centers for elective surgery."

2020 Full-Year and Fourth Quarter Financial Highlights

Full-year revenues of $429.6 million and fourth quarter revenues of $131.0 million.
Full-year GAAP net income of $145.5 million or $3.41 per share (basic) and $3.33 (diluted).
Fourth quarter GAAP net income of $14.5 million or $0.33 per share (basic) and $0.32 (diluted).
Full-year non-GAAP Adjusted EBITDA of $112.6 million and fourth quarter non-GAAP Adjusted EBITDA of $42.9 million.
Recent Business Highlights

Equity investment in GeneQuine Biotherapeutics.
In January 2021, Pacira announced an equity investment in GeneQuine Biotherapeutics GmbH. Under the terms of the agreement, Pacira made an initial investment of €2.0 million with an additional €4.0 million investment predicated upon GeneQuine achieving certain prespecified near-term milestones related to its lead gene therapy product candidate, GQ-303. Up to €2.5 million of the total Pacira investment will be in the form of a convertible note. In addition, Pacira is entitled to appoint one member to GeneQuine’s board of directors. GeneQuine Biotherapeutics is a privately held biopharmaceutical company advancing a gene therapy platform for the treatment of osteoarthritis (OA) and other musculoskeletal disorders. GeneQuine’s product candidates are next-generation gene transfer vehicles that are highly efficient in entering joint cells to confer multi-year gene expression.

European Commission approves EXPAREL for the treatment of postsurgical pain. In November 2020, the European Commission granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults. The European Commission approval was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use. These studies include: lower extremity nerve block, upper extremity nerve block, and infiltration studies in hard and soft tissue surgeries. The European Commission decision is applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein. Commercial planning is underway, with an anticipated launch in the second half of 2021.
Fourth Quarter 2020 Financial Results

Total revenues were $131.0 million in the fourth quarter of 2020, a 7% increase over the $122.4 million reported for the fourth quarter of 2019.
EXPAREL net product sales were $125.3 million in the fourth quarter of 2020, a 7% increase over the $116.9 million reported for the fourth quarter of 2019.
Fourth quarter 2020 iovera° net product sales were $2.4 million, a 25% decrease versus the $3.2 million reported in the fourth quarter of 2019.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $2.0 million in the fourth quarter of 2020, compared to $1.7 million in 2019.
Fourth quarter 2020 royalty revenue was $1.2 million compared to $0.6 million in 2019.
Total operating expenses were $112.2 million in the fourth quarter of 2020, compared to $120.7 million in the fourth quarter of 2019.
Research and development (R&D) expenses were $15.3 million in the fourth quarter of 2020, compared to $19.7 million in the fourth quarter of 2019. The company’s R&D expenses include $5.2 million and $8.7 million of product development and manufacturing capacity expansion costs in the fourth quarters of 2020 and 2019, respectively.
Selling, general and administrative (SG&A) expenses were $52.8 million in the fourth quarter of 2020, compared to $54.2 million in the fourth quarter of 2019.
GAAP net income was $14.5 million, or $0.33 per share (basic) and $0.32 (diluted), in the fourth quarter of 2020, compared to a GAAP net loss of $4.9 million, or $0.12 per share (basic and diluted), in the fourth quarter of 2019.
Non-GAAP net income was $38.8 million, or $0.89 per share (basic) and $0.87 per share (diluted), in the fourth quarter of 2020, compared to non-GAAP net income of $23.8 million, or $0.57 per share (basic) and $0.56 per share (diluted), in the fourth quarter of 2019.
Adjusted EBITDA was $42.9 million in the fourth quarter of 2020, a 48% increase over $29.1 million in the fourth quarter of 2019.
Pacira had 43.5 million basic and 44.7 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2020.
Full-Year 2020 Financial Results

Total revenues were $429.6 million in 2020, a 2% increase over the $421.0 million reported in 2019.
EXPAREL net product sales were $413.3 million in 2020, a 1% increase over the $407.9 million reported in 2019.
Full-year iovera° net product sales were $8.8 million, a 12% increase over the $7.9 million reported in 2019. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $4.5 million in 2020, compared to $3.2 million in 2019.
Full-year royalty revenue was $3.0 million compared to $2.1 million in 2019.
Total operating expenses were $383.3 million in 2020, compared to $410.5 million in 2019.
Research and development (R&D) expenses were $59.4 million in 2020, compared to $72.1 million in 2019. The company’s R&D expenses include $23.5 million and $29.7 million of product development and manufacturing capacity expansion costs in 2020 and 2019, respectively.
Selling, general and administrative (SG&A) expenses were $193.5 million in 2020, compared to $200.8 million in 2019.
GAAP net income was $145.5 million, or $3.41 per share (basic) and $3.33 per share (diluted) in 2020, compared to a GAAP net loss of $11.0 million, or $0.27 per share (basic and diluted) in 2019.
Non-GAAP net income was $96.6 million, or $2.26 per share (basic) and $2.21 per share (diluted), in 2020, compared to non-GAAP net income of $70.7 million, or $1.70 per share (basic) and $1.67 per share (diluted), in 2019.
Adjusted EBITDA was $112.6 million in 2020, a 26% increase over $89.2 million in 2019.
Pacira had 42.7 million basic and 43.7 million diluted weighted average shares of common stock outstanding in 2020.
See "Non-GAAP Financial Information" below.

Financial Guidance

The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19 to reinstate financial guidance.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, February 25, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4864607. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4864607. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense and adjusted EBITDA, because such measures exclude acquisition-related charges, product discontinuation costs and other expense; stock-based compensation; amortization of debt discount; loss on early extinguishment of debt, amortization of acquired intangible assets; an income tax benefit and a step-up in basis of inventory in connection with the acquisition of MyoScience, Inc., (gain) loss on investment and other non-operating income and the reversal of a deferred tax valuation allowance.

These measures supplement Pacira’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2021 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, including adjusted EBITDA.

On February 25, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, March 4, 2021 to report its fourth quarter and full year 2020 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, FEB 25, 2021, View Source [SID1234575625]).

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!

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 4472467. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.