On February 16, 2022 The Life Raft Group reported A recent paper published in Cancers, was the result of a global roundtable sponsored by CTOS and SPAEN (Press release, The Life Raft Group, FEB 16, 2022, View Source [SID1234608205]).

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Held on November 9, 2021, patients and advocates from Sarcoma Patients EuroNet (SPAEN) and medical experts from the Connective Tissue Oncology Society (CTOS) met as an ancillary part of the CTOS 2021 Annual meeting. Representatives from both organizations discussed the challenges and roadblocks to effective global sarcoma care and management. This paper highlights the major findings and proposes potential future steps.

Both the LRG’s Sara Rothschild, Vice President of Program Services, and Piga Fernández, LRG Global Consultant, who was also representing Fundación GIST Chile, were invited to this roundtable, as patient advocates, with the goal in mind of publishing a paper on sarcoma care and the challenges globally. Their role was to give their opinion, as patients and patient advocates on the topics that were discussed.
According to Piga, "As patient advocates, participating in this Round Table was very important. It was a great opportunity to make visible the difficult journey sarcoma patients must travel before reaching the final correct diagnosis and correct treatment. The main difficulties identified were the lack of specialists, difficult access to treatments and the long time that patients have to wait until they reach a center of excellence where they can be treated effectively. We were able to highlight the need to educate primary care professionals, to shorten the time of diagnosis, and the importance of global collaborative efforts to address the multiple problems sarcoma patients have."

According to SPAEN, "It’s a remarkable first step of a truly global initiative of Sarcoma Experts and Patient Advocates with the aim to address and overcome challenges in sarcoma care together. We brought experience and expertise from all stakeholders, from many parts of the world, from different areas of expertise together and hope to continue to do so! With hard work, enthusiasm, dedication, collaboration, and time, we aim to ultimately improve sarcoma management for patients around the globe."

On February 16, 2022 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2021 and provided financial expectations for 2022 (Press release, Alkermes, FEB 16, 2022, View Source [SID1234608172]).

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"In 2021, we made significant progress against our strategic priorities of growing our commercial business, expanding and advancing our development pipeline and driving profitability," said Richard Pops, Chief Executive Officer of Alkermes. "The year was highlighted by the FDA approval and our commercial launch of our oral atypical antipsychotic, LYBALVI, which joined ARISTADA, our long-acting injectable antipsychotic, in our psychiatry franchise. We drove new growth with VIVITROL in the alcohol dependence indication. We met important pipeline milestones, initiating potential registration-enabling studies for nemvaleukin and advancing our HDAC inhibitor and orexin development candidates. In 2022, we are focused on execution as we advance the commercial launch of LYBALVI, enroll our nemvaleukin clinical studies, demonstrate disciplined allocation of capital and manage the business to drive long-term profitability and value creation for our shareholders."

Quarter Ended Dec. 31, 2021 Financial Highlights

– Total revenues for the quarter were $324.5 million. This compared to $280.0 million for the same period in the prior year.

– Total operating expenses for the quarter were $322.1 million. This compared to $310.7 million for the same period in the prior year.

– Net income according to generally accepted accounting principles in the United States (GAAP) was $0.9 million for the quarter, or a basic and diluted GAAP earnings per share of $0.01. This compared to GAAP net loss of $42.6 million, or a basic and diluted GAAP loss per share of $0.27, for the same period in the prior year.

– Non-GAAP net income was $38.5 million for the quarter, or a non-GAAP basic earnings per share of $0.24 and diluted earnings per share of $0.23. This compared to non-GAAP net income of $16.5 million, or a non-GAAP basic and diluted earnings per share of $0.10 for the same period in the prior year.

Year Ended Dec. 31, 2021 Financial Results

Revenues

– Total revenues for the year were $1.17 billion. This compared to $1.04 billion in the prior year.

– Net sales of proprietary products for the year were $627.4 million, compared to $551.8 million in the prior year.

Net sales of VIVITROL were $343.9 million, compared to $310.7 million in the prior year, representing an increase of approximately 11%.
Net sales of ARISTADAi were $275.4 million, compared to $241.0 million in the prior year, representing an increase of approximately 14%.
Net sales of LYBALVI were $8.2 million, following commercial launch in October 2021.
– Manufacturing and royalty revenues for the year were $541.8 million, compared to $484.0 million in the prior year.

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA (the "long-acting INVEGA products") were $303.1 million, compared to $274.2 million in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA were $50.9 million, compared to $71.4 million in the prior year.
Manufacturing and royalty revenues from VUMERITY were $87.4 million, compared to $22.5 million in the prior year.
Costs and Expenses

– Total operating expenses for the year were $1.20 billion, compared to $1.15 billion in the prior year.

Cost of Goods Manufactured and Sold were $197.4 million, compared to $178.3 million in the prior year.
R&D expenses were $406.5 million, compared to $394.6 million in the prior year. R&D expenses in 2021 included a $25.0 million development milestone paid to the former shareholders of Rodin Therapeutics, Inc. related to the company’s HDAC inhibitor platform. Excluding this milestone, R&D expenses for the year were $381.5 million.
Selling, General and Administrative (SG&A) expenses were $561.0 million, compared to $538.8 million in the prior year, primarily reflecting increased investment to support the launch of LYBALVI.
Profitability

– GAAP net loss for the year was $48.2 million, or a basic and diluted GAAP loss per share of $0.30 and included the $25.0 million development milestone. This compared to GAAP net loss of $110.9 million, or a basic and diluted GAAP loss per share of $0.70, in the prior year.

– Non-GAAP net income for the year was $129.1 million, or a non-GAAP basic earnings per share of $0.80 and diluted earnings per share of $0.78 and included the $25.0 million development milestone. This compared to non-GAAP net income of $68.6 million, or a non-GAAP basic and diluted earnings per share of $0.43, in the prior year.

Balance Sheet

– At Dec. 31, 2021, Alkermes recorded cash, cash equivalents and total investments of $765.7 million, compared to $659.8 million at Dec. 31, 2020, driven primarily by the company’s operating results and changes in working capital. The company’s total debt outstanding as of Dec. 31, 2021 was $295.8 million.

"In 2021, we managed the business to achieve the high end of our overall financial expectations, as we drove topline growth, continued to optimize our cost structure and focused on operational efficiencies. At the same time, we invested in key strategic priorities including the launch of LYBALVI and the nemvaleukin development program," commented Iain Brown, Chief Financial Officer of Alkermes. "We enter 2022 in a solid financial position. Our financial expectations for the year reflect our continued focus on driving the growth of our proprietary products and disciplined capital allocation focused on opportunities with high potential return on investment in support of the company’s strategy and to drive shareholder value creation."

Financial Expectations for 2022

The following financial expectations for 2022 assume improvement in COVID-19 pandemic-related disruptions, beginning in the second quarter. If current disruptions do not decrease as anticipated, or if new COVID-19-related disruptions emerge, the company’s ability to meet these expectations could be negatively impacted. These financial expectations also reflect removal of all royalties from worldwide sales of the long-acting INVEGA products beginning in 2022. Alkermes has, to date, only received notice of partial termination relating to royalties from the long-acting INVEGA products in the U.S., after January 2022. Alkermes has not received a notice of termination from Janssen in respect of any markets outside the U.S. However, for financial planning purposes only, the company has decided to remove all royalties related to sales in markets outside the U.S. after May 2022. Alkermes continues to disagree with the position taken by Janssen and is prepared to pursue all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

All line items are according to GAAP, except as otherwise noted.

In millions (except per share amounts)

2022 Expectations

*Reflects royalties related to sales of INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA in the U.S. through January 2022 and royalties related to sales of XEPLION/TREVICTA through May 2022.

+2022 per share expectations are calculated based on a weighted average basic share count of approximately 163.0 million shares outstanding and a weighted average diluted share count of approximately 166.5 million shares outstanding.

Mr. Brown continued, "Over the last several years, we have worked to position the business such that our topline performance will be fueled primarily by the growth of our proprietary products. We estimate that the early termination of the Janssen license agreement in the United States and the impact of its potential termination outside the United States would together reduce our total revenues by approximately $260 million in 2022. From an operational perspective, we have adapted our budget, recognizing that even if we are able to favorably resolve our situation with Janssen, that resolution could take time. Today we are updating our long-term profitability targets to reflect exclusion of worldwide royalties from the long-acting INVEGA products. In the event that the situation with Janssen resolves in a manner favorable to Alkermes, or Janssen does not terminate our license agreement in markets outside the U.S., we would be positioned to accelerate the achievement of these targets. The revised profitability targets that we are announcing today reflect feedback from many of our institutional shareholders, our commitment to continued expense management and our focus on driving long-term profitability."

Profitability Targets

The company today updated its long-term profitability targets to reflect the removal of all royalty revenues related to sales of the long-acting INVEGA products in the U.S. after January 2022 and outside the U.S. after May 2022. The company is not providing reconciliations of, or comparable GAAP measures for, the following updated non-GAAP profitability targets, as they are not determinable without unreasonable efforts.*

The company is committed to achieving:

FY 2025 non-GAAP net income equal to 25% of the company’s total revenues and EBITDAii margin of 20% of total revenues
FY 2026 non-GAAP net income equal to 30% of the company’s total revenues and EBITDA margin of 25% of total revenues
As a bridge to these long-term profitability targets, the company expects to achieve non-GAAP net income in the range of 15% to 20% of the company’s total revenues in FY 2024.

Recent Events:

Psychiatry and Addiction

In October 2021, the company presented clinical data and epidemiology and health economics and outcomes research from its psychiatry and addiction portfolios at scientific conferences, including Psych Congress, the International Society for Affective Disorders (ISAD) Conference, and the Neuroscience Education Institute (NEI) Congress.
In February 2022, the company announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI compared to olanzapine on body weight in patients with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. The company plans to submit results from the ENLIGHTEN-Early study to a peer-reviewed journal for publication and present full study results at upcoming scientific meetings.
Oncology

In November 2021, the company presented data from the ION-01 study, a phase 2 trial evaluating intravenous nemvaleukin alfa ("nemvaleukin") in combination with pembrolizumab (KEYTRUDA) in patients with recurrent or metastatic head and neck squamous cell carcinoma that had previously progressed on an anti-PD-(L)1 therapy, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting.
In January 2022, the company presented a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, highlighting clinical data related to advanced GI cancers from ARTISTRY-1, a phase 1/2 study evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab, and preclinical data from the study of nemvaleukin in combination with novel agents in GI cancers.
Neuroscience

In November 2021, the company announced dosing of the first subject in a phase 1 study evaluating the safety and tolerability of ALKS 1140 in healthy adults. ALKS 1140 is designed to increase functional synaptic connections and synaptic integrity in the brain.
Corporate

In November 2021, the company announced the appointment of a new independent director, Cato T. Laurencin, M.D., Ph.D., to the company’s Board of Directors. Dr. Laurencin was designated by Sarissa Capital Management LP and certain affiliates (collectively "Sarissa") in connection with Sarissa’s April 2021 agreement with the company. Dr. Laurencin brings significant experience across a wide range of medical and scientific disciplines, strong administrative skills, and a focus on public health that is consistent with the company’s values and business strategy.
Other

In November 2021, the company announced receipt of notices of partial termination in respect of two license agreements with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson Company and, under these agreements, a licensee and recipient of Alkermes’ nanoparticulate formulation technology, known as NanoCrystal technology. The terminations impact know-how royalties related to sales of long-acting INVEGA products and other products in the United States.
Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Wednesday, Feb. 16, 2022, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Wednesday, Feb. 16, 2022, through Wednesday, Feb. 23, 2022, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13726455.

On February 16, 2022 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported the start of the second dosing cohort of the vilobelimab and PD-1 checkpoint inhibitor, pembrolizumab, combination arm of the Phase II clinical trial in cutaneous squamous cell carcinoma (cSCC) (Press release, InflaRx, FEB 16, 2022, View Source [SID1234608188]).

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The open label, non-comparative, two-stage, Phase II trial (NCT04812535) is ongoing at sites in Europe, the U.S. and elsewhere. The study is investigating two independent arms: vilobelimab alone (Arm A) and vilobelimab in combination with pembrolizumab (Arm B). The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm. The trial is expected to enroll a total of approximately 70 patients.

"We are pleased to see the progress in our first oncology study with vilobelimab and that there are to date no safety concerns in either arm," said Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx. "Scientific data suggest C5a involvement in tumor formation and progression, as well as in immunosuppression, and there is pre-clinical evidence of synergies between PD-1 and C5a/C5aR inhibitors in inducing anti-tumor responses. While there are PD-1 checkpoint inhibitors approved for the treatment of advanced cSCC, there currently are no treatment options for patients who are PD-1 checkpoint inhibitor resistant or refractory. We look forward to continuing to advance the development of vilobelimab with the hope of bringing a new therapy to treat the advanced stages of this potentially deadly skin cancer."

In the combination Arm B, three patients have been treated for at least 36 days in the first dosing cohort of the study, receiving intravenous infusions of 400 mg of vilobelimab on Days 1, 4, 8, and 15 and from Day 22 onwards, 800 mg every two weeks. Patients are also receiving 400 mg of pembrolizumab starting on Day 8 of the first cycle and every six weeks thereafter. The data from the first 36 days of treatment have been reviewed by the Steering Committee and no safety concerns were raised. The Steering Committee recommended to continue the study as planned and to open enrollment for the second dosing cohort with 1200 mg vilobelimab every two weeks after administration of 600 mg vilobelimab on Days 1,4, 8 and 15. The interim analysis in Arm B required to move to the second stage of the Phase II trial is expected after ten patients have been treated and are evaluable for response assessment at the recommended Phase II dose level, which will be selected based on data from the safety run-in phase of the study. These data are expected to be available in the first quarter of 2023.

In parallel, enrollment continues in the monotherapy Arm A. In this arm, patients are receiving a dose of 800 mg vilobelimab on Days 1, 4, 8, and 15 of the first cycle, followed by a dose of 1600 mg vilobelimab every two weeks starting on Day 22. Six patients are now enrolled in this arm. The interim analysis in Arm A required to proceed to the second stage is expected to be available after ten patients are evaluable for response assessment. These data are expected to be available in the third quarter of 2022.

About Cutaneous Squamous Cell Carcinoma (cSCC)
cSCC is the second most common form of skin cancer and, if caught early, it is generally curable. In the U.S. alone, according to the Skin Cancer Foundation, an estimated 1.8 million cases are diagnosed each year, which translates to about 205 cases diagnosed every hour. The incidence of cSCC has increased up to 200% in the past three decades. Approximately 5% of patients with cSCC develop locally advanced or metastatic disease. These forms of cSCC have a poor prognosis with low survival rates. Over 15,000 people in the U.S. die each year from this disease.

About Vilobelimab (IFX-1)
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated in pre-clinical studies to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis and pyoderma gangraenosum, as well as other areas, such as critical COVID-19 and cutaneous squamous cell carcinoma (cSCC).

On February 16, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the fourth-quarter and full-year 2021 and reaffirmed guidance for 2022 (Press release, Charles River Laboratories, FEB 16, 2022, View Source [SID1234608189]). For the quarter, revenue was $905.1 million, an increase of 14.4% from $791.0 million in the fourth quarter of 2020.

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Acquisitions contributed 5.9% to consolidated fourth-quarter revenue growth. The divestiture of the Research Models and Services operations in Japan (RMS Japan) in October 2021 reduced reported revenue growth by 1.4%. The impact of foreign currency translation reduced reported revenue growth by 0.6%. Excluding the effect of these items, organic revenue growth was 10.5%, driven by contributions from all three business segments, led by the Manufacturing segment. The comparison to the COVID-19-related impact in 2020 increased both the reported and organic revenue growth rates by 0.5% in the fourth quarter of 2021.

On a GAAP basis, fourth-quarter net income attributable to common shareholders was $137.6 million, a decrease of 3.9% from $143.2 million for the same period in 2020. Fourth quarter diluted earnings per share on a GAAP basis were $2.67, a decrease of 5.0% from $2.81 for the fourth quarter of 2020. The decreases in GAAP net income and earnings per share primarily reflected a loss from the Company’s venture capital and other strategic investments of $0.19 per share in the fourth quarter of 2021, compared to a gain of $1.01 per share for the same period in 2020. The decreases were partially offset by acquisition-related adjustments associated with contingent consideration and a gain on the sale of RMS Japan.

On a non-GAAP basis, net income was $128.4 million for the fourth quarter of 2021, an increase of 5.2% from $122.1 million for the same period in 2020. Fourth-quarter diluted earnings per share on a non-GAAP basis were $2.49, an increase of 4.2% from $2.39 per share for the fourth quarter of 2020. The increases in non-GAAP net income and earnings per share were primarily driven by higher revenue and operating income, partially offset by a higher tax rate and net interest expense.

James C. Foster, Chairman, President and Chief Executive Officer, said, "2021 was another exceptional year for Charles River, with robust revenue and earnings growth, significant operating margin expansion, and meaningful cash flow generation. This performance reflects the unprecedented demand that we are seeing across most of our businesses, as well as the breadth and scientific depth of our leading, non-clinical portfolio.

"We believe that Charles River is a stronger company today than it has ever been. We have built the leading safety assessment franchise in the world; established an integrated, end-to-end discovery offering for both small and large molecules; and most recently, a comprehensive, scientifically advanced solution for our clients’ complex biologics and cell and gene therapies. We believe that the strength of our portfolio, coupled with robust industry fundamentals and the investments that we are making to accommodate client demand, will fuel low-teens revenue growth in 2022 and enable us to achieve our strategic and financial goals," Mr. Foster concluded.

Fourth-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $165.6 million in the fourth quarter of 2021, an increase of 5.7% from $156.7 million in the fourth quarter of 2020. The impact of the RMS Japan divestiture reduced revenue by 7.2%, and the impact of foreign currency translation reduced revenue by 0.4%. Organic revenue growth of 13.3% was primarily driven by robust demand for research models, particularly in China, as well as higher revenue for research model services. Fourth quarter revenue for the cell supply business, which consists of HemaCare and Cellero, continued to be impacted by donor access and availability. The comparison to the COVID-19-related impact in 2020 increased both the reported and organic revenue growth rates by 2.3% in the fourth quarter of 2021.

In the fourth quarter of 2021, the RMS segment’s GAAP operating margin increased to 24.3% from 21.9% in the fourth quarter of 2020, and on a non-GAAP basis, the operating margin increased to 26.9% from 25.1%. The GAAP and non-GAAP operating margin increases were driven primarily by operating leverage from higher research models sales volume.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $534.1 million in the fourth quarter of 2021, an increase of 7.9% from $495.0 million in the fourth quarter of 2020. The impact of foreign currency translation reduced revenue by 0.4%, and acquisitions contributed 1.6% to DSA revenue growth. Organic revenue growth of 6.7% was driven principally by the Safety Assessment business, with the Discovery Services business also contributing.

In the fourth quarter of 2021, the DSA segment’s GAAP operating margin decreased to 17.8% from 18.4% in the fourth quarter of 2020. The decrease was primarily due to acquisition-related adjustments associated with contingent consideration. On a non-GAAP basis, the operating margin was essentially unchanged at 23.1%, compared to 23.2% in the fourth quarter of 2020. The impact of foreign currency translation reduced the DSA operating margin by approximately 40 basis points.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $205.3 million in the fourth quarter of 2021, an increase of 47.4% from $139.3 million in the fourth quarter of 2020. The acquisitions of Cognate BioServices (Cognate) and Vigene Biosciences (Vigene) contributed 27.8% to Manufacturing revenue growth, while the impact of foreign currency translation reduced revenue by 1.6%. Organic revenue growth of 21.2% was driven primarily by robust demand across the Biologics Testing Solutions, Microbial Solutions, and Avian Vaccine businesses. The comparison to the COVID-19-related impact in 2020 increased the reported and organic revenue growth rates in the fourth quarter of 2021 by 1.1% and 0.9%, respectively.

In the fourth quarter of 2021, the Manufacturing segment’s GAAP operating margin increased to 44.6% from 35.3% in the fourth quarter of 2020, primarily due to acquisition-related adjustments associated with contingent consideration. The non-GAAP operating margin decreased to 35.7% from 37.3% in the fourth quarter of 2020, driven primarily by the addition of the Cognate and Vigene CDMO businesses.

Full-Year Results

For 2021, revenue increased by 21.1% to $3.54 billion from $2.92 billion in 2020. Organic revenue growth was 15.1%. The comparison to the COVID-19-related impact in 2020 increased the reported and organic revenue growth rates in 2021 by 2.9% and 2.8%, respectively.

On a GAAP basis, net income attributable to common shareholders was $391.0 million in 2021, an increase of 7.3% from $364.3 million in 2020. Diluted earnings per share on a GAAP basis in 2021 were $7.60, an increase of 5.6% from $7.20 in 2020. On a GAAP basis, the Company recorded a loss from venture capital and other strategic investments totaling $0.44 per share in 2021, compared to a gain of $1.51 in 2020.

On a non-GAAP basis, net income was $530.5 million in 2021, an increase of 28.9% from $411.5 million in 2020. Diluted earnings per share on a non-GAAP basis in 2021 were $10.32, an increase of 26.9% from $8.13 in 2020.

Research Models and Services (RMS)

For 2021, RMS revenue was $690.4 million, an increase of 20.9% from $571.2 million in 2020. Organic revenue growth increased 19.5%. The comparison to the COVID-19-related impact in 2020 increased the reported and organic revenue growth rates in 2021 by 10.1% and 9.8%, respectively.

On a GAAP basis, the RMS segment operating margin increased to 24.2% in 2021 from 18.0% in 2020. On a non-GAAP basis, the operating margin increased to 27.3% in 2021 from 22.0% in 2020.

Discovery and Safety Assessment (DSA)

For 2021, DSA revenue was $2.11 billion, an increase of 14.7% from $1.84 billion in 2020. Organic revenue growth was 12.2%. The comparison to the COVID-19-related impact in 2020 increased both the reported and organic revenue growth rates by 0.8% in 2021.

On a GAAP basis, the DSA segment operating margin increased to 19.3% in 2021 from 17.7% in 2020. On a non-GAAP basis, the operating margin increased to 23.7% in 2021 from 23.4% in 2020.

Manufacturing Solutions (Manufacturing)

For 2021, Manufacturing revenue was $742.5 million, an increase of 44.1% from $515.4 million in 2020. Organic revenue growth was 20.6%. The comparison to the COVID-19-related impact in 2020 increased the reported and organic revenue growth rates in 2021 by 2.5% and 2.1%, respectively.

On a GAAP basis, the Manufacturing segment operating margin decreased to 33.2% in 2021 from 35.2% in 2020. On a non-GAAP basis, the operating margin decreased to 34.2% in 2021 from 37.4% in 2020.

Reaffirms 2022 Guidance

The Company is reaffirming its 2022 financial guidance, which was originally provided on January 11, 2022. As previously mentioned, the Company expects to benefit from a continuation of the robust client demand that it experienced last year and price increases, which is expected to drive low-teens revenue growth in 2022. On a non-GAAP basis, earnings per share growth in 2022 is expected to be similar to revenue growth, as modest operating margin improvement will be largely offset by less favorable below-the-line items, including a higher tax rate.

The Company’s 2022 guidance for revenue growth, earnings per share, and cash flow is as follows:

2022 GUIDANCE

Footnotes to Guidance Table:

(1) The contribution from acquisitions/divestitures (net) reflects only those transactions that were completed in 2021. The partial-year revenue impact from acquisitions, principally Cognate BioServices, Retrogenix, and Vigene Biosciences, is expected to be offset by the impact from the divestitures of RMS Japan and CDMO Sweden.

(2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, divestitures, the 53rd week in 2022, and foreign currency translation.

(3) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, and certain third-party integration costs, as well as certain costs associated with acquisition-related efficiency initiatives.

(4) These items primarily relate to charges of approximately $0.10 associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure.

Webcast

Charles River has scheduled a live webcast on Wednesday, February 16, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Citi’s 2022 Virtual Healthcare Conference Presentation

Charles River will virtually present at Citi’s 2022 Virtual Healthcare Conference, on Wednesday, February 23rd, at 9:30 a.m. ET. Management will provide an overview of Charles River’s strategic focus and business developments.

A live webcast of the presentation will be available through a link that will be posted on ir.criver.com. A webcast replay will be accessible through the same website shortly after the presentation and will remain available for approximately two weeks.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On February 16, 2022 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported the appointment of David Bharucha, M.D., Ph.D., as Chief Medical Officer, effective February 15, 2022 (Press release, Milestone Pharmaceuticals, FEB 16, 2022, View Source [SID1234608190]). Dr. Bharucha is a cardiac electrophysiologist who brings to Milestone over thirty years of global drug development and clinical experience across a range of therapeutic areas, with a focus on cardiovascular medicine. He will replace Francis Plat, M.D., who will transition to Chief Scientific Officer of the Company and, following the completion of the Phase 3 RAPID trial in the second half of 2022, will serve in an advisory capacity.

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"It is a pleasure to welcome David to the Milestone team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "His specialized training in cardiovascular rhythm disorders combined with his extensive drug development and medical experience will be invaluable as we continue to advance etripamil in patients with paroxysmal supraventricular tachycardia and atrial fibrillation with rapid ventricular rate. On behalf of the entire Milestone team, I would also like to thank Francis, who has played a foundational role in advancing the etripamil program to where it is today, for his steadfast dedication to the Company over the years and for his continued contribution as we work to gain market approval of etripamil to help patients in need."

"As we approach topline data readout of the RAPID trial expected in the second half of 2022, I firmly believe that etripamil has the potential to change the treatment paradigm for patients with episodic cardiovascular conditions," said Dr. Bharucha. "I look forward to working alongside the talented Milestone team to bring this promising therapy to as many appropriate patients as possible."

Dr. Bharucha most recently served as Vice President, Research and Development, Clinical Development at Allergan, a division of AbbVie. Prior to that, Dr. Bharucha held positions of increasing responsibility in Research and Development at Allergan, Actavis, PLC, and Forest Laboratories, where he led multiple U.S. and global programs, including in therapeutic areas of cardiovascular, internal medicine, anti-infectives, women’s health and urology, encompassing both new drug application (NDA) and label-expansion approvals. He has served on faculty at Mt. Sinai School of Medicine (NY) and Jefferson Medical University (Philadelphia). Dr. Bharucha’s training included fellowships in cardiology and electrophysiology at the Massachusetts General Hospital, Harvard Medical School. Dr. Bharucha received his M.D. (Honors) and Ph.D. (Biochemistry and Molecular Biology) from The University of Chicago, and his B.A. in Biology from Haverford College.