On August 4, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the second quarter ended June 30, 2022 (Press release, Acorda Therapeutics, AUG 4, 2022, View Source [SID1234617527]).

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"Second quarter 2022 INBRIJA U.S. net sales doubled over the first quarter of 2022, following a challenging Q1 due to the COVID Omicron surge; U.S. net sales also grew 16% over Q2 2021. New prescriptions also increased in the second quarter over the first, and continued to increase into July," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In June, Esteve launched INBRIJA in Germany. We reported $1.9 million in revenue from our distribution agreement with Esteve. Our double-digit, tiered royalties on Biogen’s ex-U.S. sales of Fampyra also reverted to us late in the second quarter, with the fulfillment of our obligation to Healthcare Royalty Partners, and we will begin to receive the full value of these royalties in the third quarter. In addition, we are pleased that Biogen has now launched Fampyra in China."

Second Quarter 2022 Financial Results

For the quarter ended June 30, 2022, the Company reported INBRIJA U.S. net revenue of $7.4 million, compared to $6.4 million for the same quarter in 2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.9 million in the second quarter related to the Esteve launch in Germany.

The Company reported AMPYRA net revenue of $18.2 million, compared to $21.8 million for the same quarter in 2021.

Research and development (R&D) expenses for the quarter ended June 30, 2022 were $1.5 million, including negligible share-based compensation expenses, compared to $2.4 million, including $0.2 million of share-based compensation for the same quarter in 2021.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2022 were $30.1 million, including $0.4 million of share-based compensation, compared to $32.4 million, including $0.7 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended June 30, 2022 was negligible, compared to $(0.8) million for the same quarter in 2021.

Provision (non-cash) for income taxes for the quarter ended June 30, 2022 was $26.6 million, compared to a benefit from income taxes of $0.5 million for the same quarter in 2021.

The Company reported a GAAP net loss of $46.7 million for the quarter ended June 30, 2022, or $2.78 per diluted share. GAAP net loss in the same quarter of 2021 was $22.9 million, or $2.29 per diluted share. The increased GAAP net loss in the current period reflects the application of Internal Revenue Code Section 382, which resulted in a reduction of the Company’s deferred tax assets with no impact to cash.

Non-GAAP net loss for the quarter ended June 30, 2022 was $52.8 million, or $3.15 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $18.7 million, or $1.87 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At June 30, 2022, the Company had cash, cash equivalents, and restricted cash of $36.5 million, compared to $65.2 million at year end 2021. Restricted cash includes $12.4 million in escrow related to the 6% semi-annual interest portion of the convertible note exchange completed in December 2019.

Financial Guidance

For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and operating expenses to be $110 – $120 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast

To participate in the Webcast, please use the following registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on August 4, 2022 until 11:59 p.m. ET on September 4, 2022. To access the replay, please dial 1 800 770 2030 (domestic) or 1 647 362 9199 (international); reference code 95455. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income (loss), adjusted to exclude the items below, and has provided 2022 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net income (loss), when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (v) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. The Company believes its non-GAAP net income (loss) measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income (loss), we have provided 2022 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile this measure to the most directly comparable GAAP financial measure is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On August 4, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, Curis, AUG 4, 2022, View Source [SID1234617526]).

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"This quarter, we issued the noteworthy first release of data from the TakeAim Lymphoma trial’s combination arm that examined emavusertib combined with ibrutinib in B cell malignancies. This data showed tumor reduction in 8 of 9 evaluable patients, and the potential to help patients experiencing ibrutinib resistance. We look forward to continuing the advancement of our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) and B cell cancers. On the administrative front, I am also pleased to announce the appointment of Diantha Duvall as our new Chief Financial Officer. Diantha brings a wealth of experience from senior roles at Merck, Biogen, Bioverativ, Genocea and PricewaterhouseCoopers. We look forward to her contributions to the Curis mission," said James Dentzer, President and Chief Executive Officer of Curis.

"I am excited to join Curis at this critical time for the company," said Ms. Duvall. "I found Curis to be particularly compelling due to its novel, targeted approach and pipeline of first-in-class cancer therapeutics with significant potential in areas of unmet need. I look forward to supporting the Curis team’s mission to develop innovative and differentiated therapeutics that improve the lives of cancer patients."

Second Quarter 2022 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

The company presented the first preliminary dataset from the combination arm in the TakeAim Lymphoma study at ASCO (Free ASCO Whitepaper) and at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress which examined the use of emavusertib plus ibrutinib in patients with relapsed or refractory (R/R) hematologic malignancies, such as non-Hodgkin’s lymphoma and other B cell malignancies. The presentation included clinical data on 13 patients who received the combination, 9 of whom had post-baseline response assessments and were evaluable for response.
Key findings in patients treated with the combination included:
The combination appeared to be well tolerated
No dose-limiting toxicities (DLTs) at 200mg of emavusertib; 2 DLTs observed at 300mg (stomatitis and syncope)
8 of 9 evaluable patients experienced reduction in tumor burden, including:
2 complete responses (CR) (primary CNS lymphoma and mantle cell lymphoma)
2 partial responses (PR) (chronic lymphocytic leukemia and mantle cell lymphoma)
One of the CRs was in a patient who had received prior treatment with ibrutinib, suggesting the combination may be able to overcome ibrutinib resistance
The company presented data from the TakeAim Leukemia study at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) during the second quarter. The data showed encouraging rates of response in three separate targeted patient populations, namely those with: spliceosome-mutated R/R AML, spliceosome-mutated R/R MDS, and FLT3-mutated R/R AML. In addition, emavusertib was well-tolerated across multiple dose levels.
The company also presented novel findings from its work involving potential biomarker development for use with emavusertib studies which described the previously unrecognized localization of IRAK4 in the nucleus of cancer cells. The localization of IRAK4 in the nucleus is being explored as a potential biomarker.
Curis’s collaborators also presented data on their work with emavusertib. Two of these were in solid tumor indications: one in gastric cancer by Dr. Kian-Huat Lim’s team at Washington University School of Medicine, and the second by Dr. Duane Mitchell’s team at the University of Florida, which investigated emavusertib in melanoma brain metastasis. The third presentation by the Company’s collaborators was also from Dr. Duane Mitchell’s team, and this work was in the treatment of patients with primary CNS lymphoma.
The company is working closely with the FDA to resolve the partial clinical holds on enrollment for the emavusertib studies.
Appointed new CFO:

Curis appointed Diantha Duvall Chief Financial Officer effective August 5, 2022. Ms. Duvall joins the company from Genocea, where she served as the CFO since 2019. Prior to that, she held senior finance roles at Bioverativ, Biogen and Merck, where her roles spanned commercial finance, venture investment, business development, joint ventures, alliances, technical accounting and controls. She received a bachelor’s degree in Economics and Public Policy from Colby College and masters’ degrees in both Accounting and Business Administration from Northeastern University. She is also a Certified Public Accountant licensed in the state of Massachusetts. Ms. Duvall succeeds Bill Steinkrauss, who as previously announced is resigning from the company on August 5, 2022, to pursue an entrepreneurial opportunity in consulting. Mr. Steinkrauss will continue to work with the company as a consultant as needed through the end of 2022 to ensure a smooth transition.
Upcoming Planned Milestones for the remainder of 2022

Report data from the TakeAim Leukemia study
We plan to present an update with additional monotherapy data
We plan to present initial data for the study of emavusertib in combination with azacitadine or venetoclax
Report data from the CI-8993 (VISTA checkpoint inhibitor) study
We plan to present an update with additional monotherapy data
Annual VISTA symposium planned for September 23, 2022
Annual IRAK4 symposium planned for October 7, 2022
Second Quarter 2022 Financial Results

For the second quarter of 2022, Curis reported a net loss of $15.9 million or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $10.8 million, or $0.12 per share on both a basic and diluted basis for the same period in 2021. Curis reported a net loss of $32.0 million or $0.35 per share on both a basic and diluted basis, for the six months ended June 30, 2022 as compared to a net loss of $20.8 million, or $0.23 per share on both a basic and diluted basis for the same period in 2021.

Revenues for the second quarter of 2022 and 2021 were $2.4 million and $2.3 million, respectively. Revenues for the six months ended June 30, 2022 and June 30, 2021 were $4.5 million. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the second quarter of 2022 were $17.5 million, as compared to $12.9 million for the same period in 2021. Operating expenses for the six months ended June 30, 2022 were $34.6 million, as compared to $23.9 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, which represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were less than $0.1 million for the second quarter of 2022 and $0.1 million for the same period in 2021. Cost of royalty revenues for the six months ended June 30, 2022 were $0.1 million, as compared to $0.2 million for the same period in 2021.

Research and Development Expenses. Research and development expenses were $12.3 million for the second quarter of 2022 as compared to $8.8 million for the same period in 2021. The increase in direct research and development expenses for the quarter is primarily attributable to increased consulting services. Additionally, personnel related costs increased by $2.5 million and stock compensation increased $0.4 million, primarily as a result of additional headcount. Research and development expenses were $23.8 million for the six months ended June 30, 2022 as compared to $15.5 million for the same period in 2021.

General and Administrative Expenses. General and administrative expenses were $5.1 million for the second quarter of 2022, as compared to $4.1 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by higher costs for personnel, stock-based compensation, and insurance costs. General and administrative expenses were $10.8 million for the six months ended June 30, 2022, as compared to $8.2 million for the same period in 2021.

Other Expense, Net. For the second quarter of 2022 and 2021, total other expense was $0.9 million and $0.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments, partially offset in the second quarter of 2021 by a gain of $0.9 million related to extinguishment of debt. Net other expense was $1.9 million for the six months ended June 30, 2022, as compared to $1.3 million for the same period in 2021.

As of June 30, 2022, Curis’s cash, cash equivalents and investments totaled $107.2 million, and there were approximately 91.8 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, August 4, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On August 4, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the second quarter ended June 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, AUG 4, 2022, View Source [SID1234617525]).

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"Following INGREZZA’s strong performance in the first half of this year, we raised full year net sales guidance. Growth continues to be driven by improving diagnosis and treatment rates for patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Although disappointed that our essential tremor data was not what we hoped to see, we look forward to the continued advancement of our pipeline with the recent FDA approval to initiate a Phase 2 proof-of-concept study for the treatment of schizophrenia with our selective M4 agonist."

Second Quarter INGREZZA Net Product Sales and Commercial Highlights:

Net product sales were $350 million with total prescriptions (TRx) of approximately 64,200
Net product sales and TRx grew 32% and 31%, respectively, vs. second quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:

Second quarter 2022 GAAP net loss and loss per share of $17 million and $0.18, respectively, compared with second quarter 2021 GAAP net income and diluted earnings per share of $42 million and $0.43, respectively, primarily driven by $70 million loss on extinguishment of debt in the second quarter of 2022.
Second quarter 2022 non-GAAP net income and diluted earnings per share of $82 million and $0.84, respectively, compared with $70 million and $0.72, respectively, for second quarter 2021.
Differences in second quarter 2022 GAAP and non-GAAP operating expenses compared with second quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio, including $30 million milestone expense incurred for our Sosei Heptares muscarinic collaboration
Increased SG&A expense primarily due to ongoing commercial initiatives, including the INGREZZA direct-to-consumer advertising campaign which launched in May 2021 and deployment of the expanded salesforce in March 2022
Total debt outstanding decreased by $211 million to $170 million following our repurchase of approximately 55% of total debt outstanding in the second quarter of 2022. The total aggregate repurchase price of $279 million was paid in cash and resulted in the recognition of a $70 million loss on extinguishment in the second quarter of 2022.
At June 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.1 billion.
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:

In June 2022, the Mitsubishi Tanabe Pharma Corporation (MTPC) launched DYSVAL (valbenazine) in Japan for the treatment of tardive dyskinesia. In connection with MTPC’s first commercial sale of DYSVAL in Japan, we received a milestone payment of $20.0 million, which was recognized as revenue in the second quarter of 2022.
In the second quarter of 2022, the FDA accepted our submission of an investigational new drug application (IND) for NBI-1117568 for the treatment of schizophrenia, for which we anticipate initiating a Phase 2 study during the second half of 2022. Based upon this progress, a milestone of $30.0 million was expensed as R&D in the second quarter of 2022, which we expect to pay to Sosei Heptares in the third quarter of 2022.
In August, the Phase 2a study of NBI-827104 in essential tremor did not meet specified endpoints. Based on the totality of data from the Phase 2a study, at this time, we do not plan to proceed further with the clinical development of NBI-827104 in essential tremor.

INGREZZA sales guidance for fiscal 2022 is based on recent trends and the anticipated benefit from our recently completed salesforce expansion. If new COVID-19 related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

GAAP R&D guidance includes (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed. GAAP R&D guidance includes approximately $40 million of milestone expenses in connection with collaborations.

Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $60 million in R&D and $110 million in SG&A.

Based upon available Federal net operating losses and tax credits, the Company expects to begin making cash payments for Federal income tax beginning in the fourth quarter of 2022.

Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On August 4, 2022 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2022 (Press release, Cerus, AUG 4, 2022, View Source [SID1234617524]).

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Recent developments and highlights include:

Second quarter 2022 total revenue of $47.6 million, reflecting a 26% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of the date of this release, the Company is reiterating its 2022 annual product revenue guidance range of $160 million to $165 million, representing a 22% to 26% increase over full-year 2021 reported product revenue.
Second quarter 2022 net loss attributable to Cerus Corporation of $8.4 million, or $0.05 per basic and diluted share, reflecting an improvement of $7.0 million over the prior year period of $15.4 million, or $0.09 per basic and diluted share, as a result of strong product revenue growth and expense management.
Non-GAAP Adjusted EBITDA for the second quarter of 2022 was negative $2.4 million, compared to negative $8.2 million during the prior year period. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.
Cerus achieved cumulative sales for the INTERCEPT Blood System for platelets and plasma that have surpassed 12 million treatable doses globally since the products were first commercially launched.
The Company announced the appointment of Hua Shan, MD, PhD, Professor of Pathology and Medical Director, Transfusion Medicine Service at Stanford Medical Center to its Board of Directors.
Cash, cash equivalents, and short-term investments were $107.0 million at June 30, 2022.
"Our second quarter 2022 results continued our multi-year trend of strong top-line growth, once again led by sales of INTERCEPT Platelets in the United States," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Despite the significant macroeconomic issues challenging various aspects of the global economy, our business has remained resilient as we support blood centers around the world in providing pathogen reduced blood components to patients."

"We are confident that the growth opportunities we have visibility into will be enough to offset the expected persistence of foreign exchange headwinds and therefore we are pleased today to reiterate our product revenue guidance of $160-165 million for the full year, driven by strong underlying demand for our products," Greenman continued. "Additionally, in light of our continued financial discipline, we believe the Company is well positioned and securely capitalized as we continue to make progress towards our goal of achieving cashflow breakeven."

Revenue

Product revenue during the second quarter of 2022 was $41.0 million, compared to $31.5 million during the prior year period. The year-over-year growth in product revenue during the quarter of 30% comes despite average EUR:USD rates coming down by more than 10% year-to-date. The reported revenue growth was led by continued strong demand for our platelet products in North America.

Second quarter 2022 government contract revenue was $6.6 million, compared to $6.3 million during the prior year period. Reported government contract revenue is comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells and sponsored efforts related to the development of next-generation pathogen reduction technology for whole blood.

Product Gross Profit & Margin

Product gross profit for the second quarter of 2022 was $21.3 million, increasing by $5.1 million over the prior year period. Product gross margin for the second quarter of 2022 was 51.9% compared to 51.3% for the second quarter of 2021, and is roughly flat compared to the first quarter of 2022.

Operating Expenses

Total operating expenses for the second quarter of 2022 were $34.7 million compared to $36.8 million for the same period of the prior year. With a core focus on disciplined financial management to improve the overall financial profile of the business, the Company continued to demonstrate operating leverage in support of its goal of achieving cashflow breakeven in the near-term.

Selling, general and administrative (SG&A) expenses for the second quarter of 2022 totaled $19.5 million, compared to $19.8 million for the second quarter of 2021, demonstrating continued leverage of the Company’s expense structure as product sales continue to ramp.

R&D expenses for the second quarter of 2022 were $15.2 million, compared to $17.1 million for the second quarter of 2021. In the second quarter, the Company’s R&D expenses declined $1.9 million on a year-over-year basis related to the timing of new product development activities.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2022 was $8.4 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $15.4 million, or $0.09 per basic and diluted share, for the second quarter of 2021.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the second quarter of 2022 was negative $2.4 million, compared to non-GAAP Adjusted EBITDA of negative $8.2 million, for the second quarter of 2021. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At June 30, 2022, the Company had cash, cash equivalents and short-term investments of $107.0 million, compared to $108.6 million at March 31, 2022.

As of June 30, 2022, the Company carried $55.0 million of notes due and a balance on its revolving line of credit of $14.9 million. The Company continues to have access to $5 million under its revolving line of credit.

For the second quarter, net cash used in operating activities totaled $0.3 million as compared to $8.7 million during the prior year period. For the first six months of 2022, net cash used in operating activities totaled $21.8 million as compared to $26.1 million during the prior year period. In both instances, increased product sales and their gross profit contribution, coupled with strong working capital management drove the improvements versus the prior year period.

Reiterating 2022 Product Revenue Guidance

The Company expects full-year 2022 product revenue will be in the range of $160-165 million, representing strong growth of approximately 22%-26% compared to full-year 2021 product revenue of $130.9 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through August 19, 2022.

On August 4, 2022 The Bayer Group reported that achieved substantial growth in the second quarter of 2022 (Press release, Bayer, AUG 4, 2022, View Source [SID1234617523]). "We delivered strong operational performance. In terms of sales, we posted significant gains at Crop Science and strong growth at Consumer Health, as well as a slight increase at Pharmaceuticals, too. And with EBITDA before special items, we even achieved growth of 30 percent," said Werner Baumann, Chairman of the Board of Management, on Thursday while presenting the company’s half-year financial report. "In view of our good business performance and higher growth expectations, we have raised our full-year guidance," he explained.

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Bayer does not currently see any material financial impact in 2022 from any potential gas supply bottlenecks as a result of the war in Ukraine, Baumann said. The company has taken steps to ensure that the direct impact of any potential gas shortages on its own production capabilities this year is contained to the greatest degree possible, he explained. "From a technical perspective, we are well prepared to significantly reduce our reliance on natural gas by switching to alternative and renewable sources of energy. We have also launched programs to save energy and have built up our stocks of products where possible." A higher degree of uncertainty stems from the company’s indirect exposure via its global supplier network, Baumann said. "That’s why we are expanding our network of suppliers and building up additional inventory of key raw materials and packaging materials."

In the second quarter of 2022, Group sales increased by 9.6 percent to 12.819 billion euros on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). EBITDA before special items advanced by 30.0 percent to 3.349 billion euros. Positive currency effects benefited sales by 915 million euros (Q2 2021: minus 524 million euros) and EBITDA before special items by 300 million euros (Q2 2021: minus 153 million euros). EBIT came in at 169 million euros (Q2 2021: minus 2.281 billion euros) after net special charges of 2.111 billion euros (Q2 2021: 3.901 billion euros) that mainly comprised 1.322 billion euros in impairment losses on intangible assets at the Crop Science Division. These impairment losses were recognized as part of impairment testing that was performed due to a strong rise in capital market interest rates. Other special charges related to ongoing litigations and restructuring measures.

Bayer has taken an additional provision of 694 million euros in the second quarter mainly due to ongoing settlement negotiations with the State of Oregon. The settlement, when finalized, would resolve a pending environmental impairment case, involving legacy Monsanto PCB products, and result in the dismissal of the case. Given the unique challenges, trial procedures, and substantive law for this case in this Oregon venue, the company decided to pursue settlement, even though Monsanto voluntarily ceased production of PCBs in 1977 and never disposed of the chemical in this state. Bayer remains committed to defend future cases through the litigation process. Recently, a Delaware State Court dismissed all of the state’s claims in a similar PCB-related case alleging environmental impairments.

Monsanto has broad indemnity agreements with its former customers and the company will pursue its rights to recover costs associated with the PCB-related litigation. The company recently filed a complaint in the Circuit Court of St. Louis County for the State of Missouri to enforce its rights.

In the second quarter, net income amounted to minus 298 million euros (Q2 2021: minus 2.335 billion euros), while core earnings per share from continuing operations rose by 19.9 percent to 1.93 euros.

Free cash flow was level with the prior-year period, at 1.140 billion euros. Net financial debt as of June 30, 2022, came in at 36.575 billion euros, up 5.9 percent from March 31, 2022.

Significantly improved market environment at Crop Science

In the agricultural business (Crop Science), Bayer increased sales by 17.2 percent (Fx & portfolio adj.) to 6.461 billion euros, driven by a substantial improvement in the market environment. The division recorded double-digit percentage growth in Latin America and Europe/Middle East/Africa, and also registered an expansion of business in North America and Asia/Pacific. Herbicides posted the strongest growth, at 51.3 percent (Fx & portfolio adj.), with sales rising particularly in Latin and North America, as well as in Europe/Middle East/Africa as a result of prices for glyphosate-based products remaining high. Sales at Corn Seed & Traits advanced by 9.5 percent (Fx & portfolio adj.), mainly due to price increases in North America, Europe/Middle East/Africa and Latin America. In addition, volumes expanded in all regions except North America. Sales at Fungicides rose by 4.3 percent (Fx & portfolio adj.), with growth in all regions except North America, where volumes declined as a result of unfavorable weather conditions. Soybean Seed & Traits saw sales decline by 16.1 percent (Fx & portfolio adj.), largely due to the significant reduction in sales from overproduction in North America and the unit’s withdrawal from the Argentinian market.

EBITDA before special items at Crop Science climbed by 71.8 percent to 1.749 billion euros. The growth in earnings was mainly driven by the substantial improvement in business performance, as well as contributions from ongoing efficiency programs. There was also a positive currency effect of 215 million euros (Q2 2021: minus 111 million euros). By contrast, earnings were diminished by an increase in costs, particularly in the cost of goods sold, which was mainly due to high inflation. The EBITDA margin before special items rose by 6.8 percentage points to 27.1 percent.

Successful product launches at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) increased by 2.1 percent (Fx & portfolio adj.) to 4.818 billion euros. The division’s new products, especially Nubeqa and Kerendia, continued their successful market launch, with sales of the cancer drug Nubeqa doubling compared with the prior-year quarter. However, overall sales growth was held back by additional tender procedures in China, particularly for the cancer drug Nexavar and the oral anticoagulant Xarelto, which saw their global sales fall by 29.5 percent (Fx & portfolio adj.) and 6.4 percent (Fx & portfolio adj.), respectively. Xarelto sales were also impacted by the expiration of the product’s patent in Brazil. By contrast, sales of the ophthalmology drug Eylea rose by 11.7 percent (Fx & portfolio adj.), with business up in all regions. The company was able to capture market share, particularly in Europe, thanks in part to Eylea prefilled syringes. The division also registered significant growth for Adalat, its heart disease treatment, and Aspirin Cardio, its product for secondary prevention of heart attacks. Sales of these two products were up 11.2 percent (Fx & portfolio adj.) and 18.9 percent (Fx & portfolio adj.), respectively, due to higher volumes in China. Sales of the cancer drug Stivarga increased at an even stronger rate of 27.6 percent (Fx & portfolio adj.), mainly driven by expanded volumes in China and the United States.

EBITDA before special items at Pharmaceuticals advanced by 4.9 percent to 1.478 billion euros. Higher raw material costs and increased marketing investments in new products were largely offset by the growth in sales. The division also generated income from the sale of non-core businesses. There were positive currency effects of 41 million euros (Q2 2021: minus 26 million euros). The EBITDA margin before special items amounted to 30.7 percent.

Consumer Health grows business in all regions

Bayer’s sales of self-care products (Consumer Health) advanced by 6.8 percent (Fx & portfolio adj.) to 1.496 billion euros, with broad-based growth in all regions and nearly all categories. Sales in the Allergy & Cold category rose by 16.9 percent (Fx & portfolio adj.), largely due to continuously high cold incidence rates in Europe and North America. In June, the division also started selling Astepro, a product that it switched from Rx to OTC status. As the first and only steroid-free antihistamine nasal spray available over the counter on the U.S. market, Astepro is a differentiated, fast-working solution. Sales rose by a double-digit percentage (Fx & portfolio adj.) in the Digestive Health category as well, and the Dermatology and Pain & Cardio categories also recorded significant growth. After posting substantial gains since 2020, sales in the Nutritionals category declined by 3.7 percent (Fx & portfolio adj.) but remained at a high level overall.

EBITDA before special items at Consumer Health climbed by 18.7 percent to 330 million euros. The growth in earnings was on the back of a strong rise in sales, as well as the division’s continuous cost and price management efforts in an environment of accelerating inflation. There were also positive currency effects of 49 million euros (Q2 2021: minus 20 million euros). The EBITDA margin before special items rose by 0.5 percentage points to 22.1 percent.

Outlook for 2022 raised

Following the positive development of business in the first half of 2022, Bayer remains optimistic for the remainder of the year. It has therefore raised its guidance for the Crop Science and Consumer Health divisions, and thus also for the Group as a whole.

On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2021), Bayer now expects to generate sales of 47 billion to 48 billion euros in 2022 (previously: approximately 46 billion euros). This now corresponds to an increase of about 8 percent (previously: around 5 percent) on a currency- and portfolio-adjusted basis. The company is now targeting an EBITDA margin before special items of around 26 to 27 percent (previously: around 26 percent) on a currency-adjusted basis. Based on the aforementioned sales figure, this would now correspond to EBITDA before special items of around 12.5 billion euros (previously: around 12.0 billion euros) on a currency-adjusted basis. Core earnings per share are now expected to come in at approximately 7.30 euros (previously: approximately 7.00 euros) on a currency-adjusted basis. Free cash flow is now forecast to amount to around 2.5 billion euros (previously: around 2 billion to 2.5 billion euros) on a currency-adjusted basis. In addition, the company continues to expect year-end net financial debt of approximately 33 billion to 34 billion euros on a currency-adjusted basis. As in the overall guidance, this figure does not take into account the contractually agreed divestment of the Environmental Science Professional business.

Bayer has also prepared its guidance based on the closing exchange rates as of June 30, 2022, and the differences to the currency-adjusted targets above are as follows: the company now expects to generate sales of 50 billion to 51 billion euros (previously: approximately 47 billion euros). Based on the aforementioned sales figure, Bayer is now targeting EBITDA before special items of around 13.0 billion euros (previously: around 12.0 billion euros). Core earnings per share are now expected to come in at approximately 7.70 euros (previously: approximately 7.10 euros). In addition, the company now expects year-end net financial debt of approximately 34 billion to 35 billion euros (previously: approximately 33 billion to 34 billion euros).

Sustainability: access to innovative seeds and farming solutions

Bayer also continued to make good progress in terms of sustainability. The company is supporting the Zero Hunger Pledge, which will involve helping smallholder farmers access innovative seeds, sustainable agricultural practices and farming solutions, and thus providing them with new income-generating opportunities.

Bayer has also made important progress in a major ESG rating: MSCI ESG Research recently updated their ESG Controversies Report and lifted the red flag related to "environmental concerns over GMO crops" as well as their related allegation of a breach of the UN Global Compact Principles. This marks another important milestone in improving Bayer’s ESG rating profile.