On February 22, 2022 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Cerus, FEB 22, 2022, View Source [SID1234608796]).

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Recent developments and highlights include:

Fourth quarter 2021 total revenue of $50.1 million, reflecting a 49% increase over the prior year period. For the full year, 2021 total revenue was $159.5 million, reflecting a 40% 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 $157 million to $164 million, representing a 20% to 25% increase over full-year 2021 reported product revenue.
This year, Cerus Corporation celebrates its 30th anniversary. Since its foundation, Cerus has recognized the critical unmet need to protect the world’s blood supply. With the INTERCEPT Blood System, Cerus hopes to continue to deliver innovative solutions in support of making safe blood products accessible globally.
Two of the Company’s blood center production partners, Gulf Coast Regional Blood Center and Central California Blood Center (CCBC), have recently obtained BLA approvals for the INTERCEPT Blood System for Cryoprecipitation, which is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, or INTERCEPT Fibrinogen Complex (IFC). With these BLA approvals, the Company and these blood center production partners have the ability to sell IFC across state lines.
Cash, cash equivalents, and short-term investments were $129.4 million at December 31, 2021.
"2021 was a breakout year for Cerus. We solidified a leadership position in the U.S. platelet market with blood centers and their hospital customers that chose INTERCEPT platelets for their patients to comply with the FDA’s platelet bacterial safety guidance," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With the INTERCEPT Blood System now established in many blood centers in the U.S., we are confident that 2022 will be another year of strong growth led by sales of INTERCEPT platelet kits. At the same time, we are excited to continue our IFC launch across the country on the heels of the recent first BLA approvals as well as collaborations with BCA and OneBlood. We look forward to continuing to expand patient access to INTERCEPT treated blood components and updating our stakeholders on our progress throughout the year."

Revenue

Product revenue during the fourth quarter of 2021 was $39.9 million, compared to $28.2 million during the prior year period. Product revenue growth during the quarter and full year was driven by increased sales of INTERCEPT platelet kits to blood center customers across the U.S.

Fourth quarter 2021 government contract revenue was $10.2 million, compared to $5.4 million during the prior year period. Reported government contract revenue in the fourth quarter 2021 increased versus the prior year period following an agreement for allowable costs that the Company had previously been deferring. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells as well as sponsored efforts related to the development of next-generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the fourth quarter 2021 was $20.4 million and, for the second consecutive quarter, was the highest in the Company’s history, increasing by $4.4 million over the prior year period. Product gross margin for the fourth quarter 2021 was 51.1% compared to 56.8% for the fourth quarter of 2020 and roughly flat compared to the second and third quarters of 2021.

Full-year 2021 product gross profit was $67.4 million and reflected growth of 33% over the prior year. Product gross margin for the full year 2021 was 51.5% compared to 55.2% for the prior year.

For both the fourth quarter and full year, the year-over-year decreases in product gross margin was anticipated. Currently, U.S. customers primarily use single dose platelet kits, which have a lower product gross margin percentage as compared to our double dose kits, which are more typically used by the Company’s international customers.

Operating Expenses

Total operating expenses for the fourth quarter of 2021 were $37.6 million compared to $35.8 million for the same period of the prior year, reflecting a year-over-year increase of 5%. For the full year, 2021 total operating expenses totaled $145.0 million, representing an increase of 10% when compared to 2020 total operating expenses of $131.4 million. On both a quarterly and full-year basis, lower R&D expenses versus the prior year periods were offset by higher commercial expenses, driven by sales incentive compensation.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2021 totaled $22.0 million, compared to $18.7 million for the fourth quarter of 2020. For the full year 2021, SG&A expenses totaled $81.3 million, compared to $67.0 million for the full year 2020. The year-over-year increase in SG&A expenses for the fourth quarter and full year was tied to higher non-cash stock-based compensation expense, increased sales incentive costs and continued investments in the Company’s therapeutics business unit.

R&D expenses for the fourth quarter of 2021 were $15.6 million, compared to $17.1 million for the fourth quarter of 2020. For the full year, 2021 R&D expenses totaled $63.7 million, compared to $64.4 million for the full year 2020. For both the fourth quarter and full year, the Company’s R&D expenses continued to advance the Company’s key pipeline programs, including development of the Company’s LED illuminator and INTERCEPT Red Blood Cell program, but were offset by lower R&D costs versus the prior year periods as other projects reached completion.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the fourth quarter of 2021 was $9.1 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $14.4 million, or $0.09 per basic and diluted share, for the fourth quarter of 2020.

For the full year 2021, net loss attributable to Cerus Corporation was $54.4 million, or $0.32 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $59.9 million, or $0.37 per basic and diluted share for the full year 2020.

Balance Sheet & Cash Use

At December 31, 2021, the Company had cash, cash equivalents and short-term investments of $129.4 million, compared to $120.0 million at September 30, 2021, and $133.6 million at December 31, 2020.

As of December 31, 2021, the Company carried $54.7 million of notes due and a balance on its revolving line of credit of $14.7 million. The Company continues to have access to $5 million under its revolving line of credit.

For the fourth quarter of 2021, net cash used in operating activities totaled $1.2 million as compared to $8.9 million during the prior year period, continuing a trend of strong capital management as higher revenues and significant operating leverage offset investments in inventory to continue to meet growing customer demand. For the full year 2021, net cash used in operating activities totaled $33.9 million, compared with $41.8 million for the full year 2020.

Reiterating 2022 Product Revenue Guidance

The Company expects full-year 2022 product revenue will be in the range of $157-$164 million, representing strong growth of approximately 20%-25% 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. EST 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 Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8851919. The replay will be available approximately three hours after the call through March 8, 2022.

On February 22, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its fourth quarter and year end 2021 financial results after market close on Tuesday, March 1, 2022 (Press release, Rigel, FEB 22, 2022, View Source [SID1234608812]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

On February 22, 2022 BostonGene reported its publication, "Conserved pan-cancer microenvironment subtypes predict response to immunotherapy," has been selected by Cancer Cell as one of ten research articles that represent cutting-edge areas of cancer research and oncology in 2021 (Press release, BostonGene, FEB 22, 2022, View Source [SID1234608830]).

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The manuscript describes a transcriptomic-based tumor classification platform that identified four unique tumor microenvironment subtypes across 20 different cancers, predicting prognosis and response to immune checkpoint blockade. BostonGene also created a personalized tumor map to visually depict the key molecular and immune characteristics of each tumor. The microenvironment classification platform and tumor map provide a clinically useful and robust methodology for response prediction and incorporate precision medicine strategies across varied cancer types.

"We are thrilled to be recognized by Cancer Cell for our innovative multi-platform analytics combined with cutting-edge software to improve patient outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings underscore the power of integrated analysis to uncover unique and clinically applicable characteristics of the tumor microenvironment, and we are committed to enabling doctors to personalize therapy for cancer patients."

The research results provided the foundation to launch BostonGene Tumor PortraitTM Tests, which are designed to reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.

On February 22, 2022 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the fourth quarter and year ended December 31, 2021 and corporate highlights (Press release, Apollo Endosurgery, FEB 22, 2022, View Source [SID1234608849]).

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Fourth Quarter and Full Year Financial and Corporate Highlights
•Grew fourth quarter 2021 and full year Endoscopic Suturing System (ESS) revenue 37% and 55% over the same periods in 2020;
•Grew fourth quarter 2021 and full year Intragastric Balloon (IGB) revenue 20% and 50% over the same periods of 2020;
•Increased fourth quarter 2021 and full year revenue from the Company’s top 10 direct accounts by over 50% and 85% over the same periods in 2020;
•Continued X-Tack penetration in key accounts, with fourth quarter 2021 revenue growth of nearly 40% and an increase in ordering customers of nearly 20% compared to the third quarter 2021;
•Secured over $175 million in new capital and borrowing capacity, providing cash runway to fund Apollo’s planned growth initiatives;
•Announced that investigators in the Multi-Center ESG Randomized Interventional (MERIT) study reported that the study met its primary endpoints for safety and efficacy. Patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) achieved excess body weight loss of 49.2% at 12 months and demonstrated improvements in weight-related comorbidities. The MERIT study reported a serious adverse event rate of 2% for patients undergoing the ESG procedure.
•Submitted a De Novo classification request to the U.S. Food and Drug Administration seeking 510(k) classification and clearance for the Apollo ESGTM and Apollo REVISETM devices; and
•Announced the publication of a multi-center study of Apollo’s X-Tack System, demonstrating high success rates, ease of use, and economic value in the treatment of GI defects.
"The fourth quarter capped a transformative year at Apollo, during which we drove increased utilization of our innovative therapeutic endoscopy portfolio, positioned the Company to expand our reach into new indications such as our recent De Novo 510(k) classification request for Apollo ESG and Apollo REVISE, and significantly enhanced our balance sheet to support our growth runway," said Chas McKhann, Apollo’s president and CEO. "We remain focused on long-term value creation, expanding our base of trained physicians, working closely with our customers to drive product utilization, and maximizing the impact of our expanded sales team."

Comparison of Selected GAAP and Non-GAAP Financial Results for Fourth Quarter 2021 to Fourth Quarter 2020
Total worldwide revenue increased to $16.2 million in the fourth quarter of 2021, a 26% increase compared to the fourth quarter of 2020, despite the impact of the recent surge in COVID-19 cases, which pressured procedural volumes in several key geographies, both domestic and international.
ESS product sales increased $2.8 million, or 37% in the fourth quarter of 2021 compared to 2020. Fourth quarter U.S. ESS product sales increased 42% while OUS ESS product sales increased 29%, highlighting continued demand for Apollo’s OverStitch and X-Tack products across a range of patient indications. IGB product sales increased $0.9 million, or 20%, during the fourth quarter 2021 compared to the fourth quarter 2020 reflecting continued strength in demand for the ORBERA balloon. In the U.S., IGB product sales increased 6% while OUS IGB product sales increased 27%.
Gross margin increased by 40 basis points, from 55.9% to 56.3%, and was $9.1 million for the fourth quarter 2021 compared to $7.2 million for the fourth quarter 2020.
Total operating expenses in the fourth quarter were $14.8 million compared to $10.4 million in the fourth quarter 2020. Excluding stock-based compensation, total non-GAAP adjusted operating expenses increased to $13.3 million from $9.8 million in 2020, primarily reflecting increased sales and marketing expenses to support current and anticipated revenue growth.
Loss from operations in the fourth quarter 2021 was $5.7 million compared to $3.2 million in the fourth quarter 2020. Net loss in the fourth quarter of 2021 was $10.4 million compared to $3.5 million in the fourth quarter of 2020, driven largely by an increase in interest expense related to a write-off of deferred financing costs and fees associated with the Company’s debt refinancing in December 2021. Non-GAAP adjusted EBITDA, which excludes stock-based compensation, gain on forgiveness of PPP loan and unrealized foreign exchange was a loss of $3.5 million for the fourth quarter of 2021, compared to a loss of $1.7 million in the fourth quarter 2020.
For more detailed information on non-GAAP calculations, please refer to the tables that follow.
Cash, cash equivalents and restricted cash were $91.8 million as of December 31, 2021, with up to an additional $65.0 million in future draws available under the Company’s credit facility with Innovatus Capital Partners should the Company meet certain revenue milestones.
Current and long-term debt at face value as of December 31, 2021 included $35.0 million outstanding under the Innovatus credit facility and $19.5 million in outstanding convertible notes.
Financial Outlook for 2022
Apollo expects full year 2022 revenue between $73 million and $75 million, representing growth of approximately 16% to 19% over 2021. The Company continues to monitor the potential and uncertain impact of the ongoing COVID-19 pandemic. Should hospitals or outpatient centers, where the company’s procedures are performed, experience continued or additional surges in cases, and need to defer elective procedures to preserve capacity for COVID-19 patients, the company’s ability to achieve these financial projections could be adversely affected.
Resignation of Bruce Robertson from Apollo Board of Directors
Apollo also announced today that Bruce Robertson has retired from the Apollo Board of Directors, effective immediately, to focus on other commitments. Dr. Robertson, Managing Director of H.I.G. Capital, LLC, has served as a member of the Apollo Board of Directors since February 2008.
"Bruce has been instrumental in Apollo’s development in his 14 years of service on our Board," said Chas McKhann. "Personally, he has been a highly valued colleague and advisor in my first year as CEO. We thank Bruce for his unwavering contributions to Apollo’s formation and growth, and we wish him all the best in his future endeavors."
"Since our initial investment in Apollo, my colleagues at H.I.G. Capital and I have been excited about the Company’s potential to play a transformative role in therapeutic endoscopy," said Dr. Robertson, "I leave knowing that Apollo is in good hands under a new leadership team, with a sound strategy to realize the full potential of our original vision."
The Company has engaged Spencer Stuart, a global executive search firm, to lead a search process for Dr. Robertson’s successor.

Conference Call
Apollo will host a live webcast audio call with slides today at 3:30 p.m. CT / 4:30 p.m. ET. Investors are invited to join the live call via webcast from the Investors section of the Company’s corporate website at www.apolloendo.com. An audio-only option is available by dialing +1 973-528-0011 and referencing access code 718442 or the "Apollo Endosurgery Fourth Quarter 2021 Earnings Call." Investors who opt for audio-only will need to download the related slides at www.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com, shortly after completion of the call.
Non-GAAP Financial Measures
To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures, including non-GAAP adjusted operating expenses and non-GAAP Adjusted EBITDA. Adjusted operating expenses is calculated as operating expense less stock-based compensation. Adjusted EBITDA is calculated as GAAP net loss, plus depreciation and amortization, interest expense, net, income tax expense, stock-based compensation, gain on forgiveness of PPP loan, and unrealized foreign exchange. These supplemental measures of our performance are not required by, and are not determined in accordance with GAAP. The Company believes that these non-GAAP financial measures provide investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company. The Company’s non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently. Non-GAAP financial results should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Included in the supplemental tables to this press release is a reconciliation of non-GAAP adjusted EBITDA to GAAP net loss.

On February 22, 2022 Statera Biopharma, Inc. (NASDAQ: STAB) (the "Company" or "Statera Biopharma"), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported unaudited, preliminary revenue and other financial results for its Fiscal Year ended December 31, 2021 (Press release, Cleveland BioLabs, FEB 22, 2022, View Source [SID1234608797]).

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Revenues for the year ended December 31, 2021 were $1,487,036 representing an increase of 100%, from $0 for the same period in 2020. The increase in revenues was due to the acquisition of ImQuest Life Sciences, Inc. and its subsidiaries (ImQuest) in June 2021 by Old Cytocom. ImQuest is a research and development company focused specifically on cancer, inflammation and infectious disease treatments. The Company reported no revenue in 2020.

Cost of revenues for the year ended December 31, 2021 was $488,314, representing an increase 100% for the same period in 2020. The increase was due to the acquisition of ImQuest. Cost of revenues as a percentage of revenue was 33% for the year ended December 31, 2021.

Operating costs for the year ended December 31, 2021 were $31,587,009, representing an increase of $20,086,619, or 191%, from $10,501,668 for the 2020. The increase in operating costs was principally due to increases in research and development expense (an increase of $6,566,403 or 125% year over year) and general and administrative expense (an increase of $14,441,905 or 276% year over year). The increase in research and development expense was the result of increased costs for the expansion in 2021 of clinical trial programs for Crohn’s disease and COVID-19. The increase in general and administrative expense reflects the costs incurred for the Merger and Old Cytocom’s acquisition of ImQuest, legal and other fees incurred to raise additional capital in 2021, increases in employee compensation, benefits and stock based compensation, and insurance expense.

Other expense for the year ended December 31, 2021 was $4,328,823, representing an increase of $2,736,630, or 172%, from other expense of $1,592,193 for the same period in 2020. The change is due to an increase of $5,458,954 in interest and other non-operating expense, offset by an increase of $2,722,324 in gains on extinguishment of debt.

Net loss attributed to the Company for the year ended December 31, 2021 was $34,892,762, representing an increase of $22,798,701, or 189%, from $12,093,861 for the same period in 2020. The increase in net loss is principally due to the increase in operating expense for the reasons described above.

Michael K. Handley, the Company’s CEO, stated, "We have taken numerous steps to further the development of our clinical stage pipeline that has us well-positioned to achieve numerous milestones in 2022. Following the recent submission to the FDA of our Phase 3 clinical trial protocol for STAT-201 in the treatment of pediatric Crohn’s Disease, we plan to use proceeds from our recent registered direct offering to initiate patient enrollment in the second quarter. Additionally, use of proceeds will include the enrollment of patients with acute COVID-19 infection in our STAT-205 study, from which we are targeting to have preliminary data this year."