On May 9, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Adaptimmune, MAY 9, 2022, View Source [SID1234613880]).

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"We have four clear areas of focus this year: to file the BLA for afami-cel, continue to build our MAGE-A4 franchise, scale up our manufacturing capabilities, and continue to advance our allogeneic products. We have made good progress with each in 2022," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We remain funded into early 2024 and will continue to execute across these objectives."

Roadmap to BLA submission for afami-cel1 in 2022 (first-generation product targeting MAGE-A4)

Adaptimmune is preparing the BLA and targeting submission to the US Food and Drug Administration (FDA) in Q4 2022 for the treatment of synovial sarcoma.
Updated data based on pooled analyses of characteristics associated with clinical responses from Cohort 1 of the SPEARHEAD-1 trial and the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma to be presented in a poster at ASCO (Free ASCO Whitepaper).
Preclinical data at the American Society for Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference

Preclinical data from the next-generation SPEAR T-cell targeting MAGE-A4 incorporating IL-7 and CCL19 (ADP-A2M4N7X19), developed in collaboration with Noile-Immune, to be presented in a poster; the Company plans to file an IND for this next-generation SPEAR T-cell later this year.
Preclinical data from tumor-infiltrating lymphocytes (TILs) incorporating IL-7 (TIL-IL7), being developed in collaboration with the Center for Cancer Immune Therapy in Denmark, to be presented in a poster; a single-center clinical trial is planned for initiation in 2022.
Corporate
The Company appointed Dr. Joanna (Jo) Brewer as its Chief Scientific Officer effective May 4; Dr. Brewer previously served as the Company’s SVP Allogeneic Research.

Financial Results for the three months ended March 31, 2022

Cash / liquidity position: As of March 31, 2022, Adaptimmune had cash and cash equivalents of $89.5 million and Total Liquidity2 of $304.2 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
Revenue: Revenue for the three months ended March 31, 2022 was $3.6 million, compared to $0.4 million for the same period in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $36.8 million, compared to $24.5 million for the same period in 2021. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in subcontracted expenditures, increases in in-process research and development costs and a decrease in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $16.8 million, compared to $13.8 million for the same period in 2021 due to increases in employee-related costs and other corporate costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2022 was $50.3 million ($(0.05) per ordinary share), compared to $37.8 million ($(0.04) per ordinary share) for the same period in 2021.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2022. The live webcast of the conference call will be available via the Events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6779362).

On May 9, 2022 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the first quarter ended March 31, 2022 and provided an update on key strategic initiatives (Press release, BioXcel, MAY 9, 2022, View Source [SID1234613879]).

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"2022 has already been a transformative year during which we have made monumental progress on our journey to become the leading AI-enabled neuroscience company. Our recent achievements across our clinical, business, and commercial priorities, highlighted by our first FDA approval of IGALMI, have positioned us to realize our 2022 goals and beyond," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "Building on this momentum, we are excited to launch IGALMI, advance our proven technology, and continue delivering innovative medicines to patients and caregivers."

Company Highlights

Neuroscience Franchise

IGALMI Approval and Commercial Launch

IGALMI was approved by the FDA on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.1 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.2-4

The Company is focused on the following key commercial launch activities to provide access to patients and caregivers:

·Institutional Sales Force: Seasoned sales specialists were onboarded, undergoing training, and will be deployed for launch. The team has an average of over 21 years of industry experience, 14 years in hospital settings, and 8 product launches.
oLaunch meeting to be held in mid-May in preparation for national salesforce deployment on May 23rd across priority regions and customers.
·Market Access Team: Currently engaging with group purchasing organizations (GPOs) and high value Integrated Delivery Networks (IDNs).
·Trade Launch: Product load into distribution channels in Q3 2022.

Clinical Pipeline

BXCL501, a proprietary, sublingual film formulation of dexmedetomidine, is being investigated in multiple neuropsychiatric conditions. BXCL501 has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

Indication Expansion

·Alzheimer’s Disease-related Agitation: TRANQUILITY program designed to maximize BXCL501 opportunity to treat Alzheimer’s Disease-related agitation. There are an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually.5
oTRANQUILITY II: First patient dosed; top-line data readout in Q4 2022/early Q1 2023.
oTRANQUILITY III: Trial underway with enrollment initiating in 2H 2022.
oSelection of 40 mcg and 60 mcg dosing regimens in pivotal trial supported by breakthrough designation from the FDA, along with positive efficacy, safety, and tolerability data observed in 100 patients in the Phase 1b/2 TRANQUILITY trial and a recent study of BXCL501 40 mcg.

·Adjunctive Treatment for Major Depressive Disorder (MDD): Initiated Phase 1 multiple ascending dose trial in healthy volunteers.

Geographic Expansion

·Marketing Authorization Application: Submission to the European Medicines Agency (EMA) for BXCL501 for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults in 2Q 2022.
·Japan Entry: Company exploring market entry strategies to expand access of IGALMI to patients in Japan.

OnkosXcel Therapeutics

Established OnkosXcel Therapeutics as a wholly owned subsidiary to focus on the sustained expansion and optimization of the Company’s immuno-oncology (I-O) franchise, including its most advanced I-O program, BXCL701. BXCL701 is an investigational, orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

·Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Following positive Phase 2 data for BXCL701 in combination with KEYTRUDA (pembrolizumab) announced this past February, continued ongoing Phase 2 trial in mCRPC patients with either small cell neuroendocrine carcinoma (SCNC) or adenocarcinoma phenotype.
oExpect to complete enrollment of 28-patient SCNC cohort in 2H 2022.
oFirst patient enrolled in adenocarcinoma randomized trial expansion evaluating BXCL701 monotherapy vs. BXCL701-KEYTRUDA combination therapy.

·Solid Tumors Program (Checkpoint Naïve and Refractory): Additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA is expected in 2H 2022.

Strategic Financing

·Announced $260 Million Strategic Financing with Oaktree and Qatar Investment Authority: Full execution of this financing would extend the Company’s cash runway into 2025 to support the commercial launch of IGALMI and achieve key clinical and regulatory milestones.

First Quarter 2022 Financial Results

Research and Development Expenses: Research and development expenses were $18.6 million for the first quarter of 2022, compared to $14.7 million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company’s TRANQUILITY program.

General and Administrative Expenses: General and administrative expenses were $12.9 million for the first quarter of 2022, as compared to $11.6 million for the same period in 2021. The increase was primarily due to personnel and costs related to the commercial launch readiness efforts for IGALMI in the U.S.

Net Loss: BioXcel Therapeutics reported a net loss of $31.5 million for the first quarter of 2022, compared to a net loss of $26.4 million for the same period in 2021.

As of March 31, 2022, cash and cash equivalents totaled approximately $200 million. This excludes contributions from the $260 million strategic financing announced in April. To date the Company has drawn $70M of the loan agreement and has met the milestone to receive $30M of the royalty financing which is expected to be drawn in the second quarter of 2022.

Conference Call

BioXcel Therapeutics will host a conference call and webcast May 9, 2022, at 8:30 a.m., ET, to discuss its first quarter 2022 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through August 9, 2022.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

About TRANQUILITY II and III

Initiated in December of 2021, TRANQUILITY II and III are pivotal Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with Alzheimer’s disease. The trials expand the evaluation of patients who experience agitation across diverse medical settings and across the range of dementia severity. TRANQUILITY II and III are designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with AD. Each trial will enroll approximately 150 dementia patients 65 years and older who will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period. TRANQUILITY II will assess patients in assisted living or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing in nursing homes with moderate to severe dementia and require moderate or greater assistance with activities of daily living. The studies will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies is change in PEC score from baseline measured at two hours after the initial dose and subsequent doses.

On May 9, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2022 as well as upcoming anticipated corporate milestones.

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"The first quarter of 2022 marked the beginning of a data-rich year for Surface, starting with the presentation of preclinical and translational SRF388 data at AACR (Free AACR Whitepaper) in April," said Rob Ross, M.D., chief executive officer. "We are actively developing two novel antibodies in Phase 2 studies, SRF388 and SRF617, and our runway now provides us with 12 months of cash beyond data readouts for up to six different indications and combination studies across the programs. We look forward to presenting our next update on SRF388, the only antibody targeting IL-27 in the clinic, at ASCO (Free ASCO Whitepaper), and we remain on track to share new clinical data for SRF617 in the second half of this year."

First Quarter and Subsequent Corporate Highlights

During the first quarter, Surface raised net proceeds of approximately $21 million through the company’s existing At-the-Market (ATM) facility with participation based on unsolicited interest received from EcoR1 and Octagon Capital Advisors.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, Surface presented SRF388 preclinical and translational data supporting the recommended Phase 2 monotherapy dose selection of 10 mg/kg administered intravenously every four weeks. This dose is being studied in dedicated expansion cohorts of treatment-refractory clear cell renal cell carcinoma (ccRCC), non-small-cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC).

In March, Surface announced that the first patient had been dosed by GlaxoSmithKline (GSK) in a Phase 1 study evaluating GSK4381562 in patients with solid tumors. GSK4381562 is a fully human IgG1 antibody targeting PVRIG, an inhibitory protein on the TIGIT/DNAM/TACTILE axis that is expressed on natural killer cells (NK cells) and T cells. As a result, Surface is entitled to a $30 million milestone payment and is eligible to receive an additional $700 million in potential future milestone payments, and tiered royalties on global net sales.

In March, the company announced the appointment of Theresa Boni, J.D., as general counsel and senior vice president, legal. Ms. Boni brings more than 20 years of legal experience spanning the biopharmaceutical and medical device industries.
SRF388 Clinical Trial Progress and Updates

In April 2022, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388, a potential first-in-class antibody against IL-27. The initiations include the first patient dosed in a Phase 2 monotherapy clinical study in treatment-refractory NSCLC patients and the first patient dosed in the lead-in to a randomized Phase 2 clinical study in combination with atezolizumab and bevacizumab in patients with HCC who have not received prior systemic treatment (first-line).

With respect to the design of the SRF388 randomized Phase 2 study in first-line HCC, the company will expand the open-label lead-in from six patients, as originally planned, to approximately 30 patients. Management believes this expanded lead-in will provide more robust safety and efficacy data to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection. Data from the lead-in are anticipated in the first half of 2023.

New clinical data on SRF388 will be presented in an oral session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. The session, entitled "First-in-human study of SRF388, a first-in-class IL-27 targeting antibody, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors," will be held Saturday, June 4, 2022, from 1:15 pm – 4:15 pm CDT.
Selected Anticipated Near-term Corporate Milestones

The company remains on track to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the second half of 2022.

Surface anticipates filing an Investigational New Drug application for SRF114, a fully human IgG1 anti-CCR8 antibody, in the second half of 2022.
Financial Results
As of March 31, 2022, cash, cash equivalents and marketable securities were $150.4 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.5 million for the first quarter ended March 31, 2022, compared to $5.6 million for the same period in 2021. This increase was primarily due to increases in personnel and facility-related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the first quarter ended March 31, 2022.

Research and development (R&D) expenses were $16.6 million for the first quarter ended March 31, 2022, compared to $10.5 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 clinical trials and advancement into Phase 2 trials. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter ended March 31, 2022.

For the first quarter ended March 31, 2022, net income was $6.2 million, or basic net income per share of $0.13 and diluted net income per share of $0.13. Net loss was $15.6 million for the same period in 2021, or basic and diluted net loss per share of $0.37.

Based upon the current operating plan, Surface projects its cash runway extending into 2024.

On May 9, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it will release first quarter 2022 financial results before the market open on Monday, May 16, 2022 (Press release, Hookipa Pharma, MAY 9, 2022, View Source [SID1234613877]).

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The Company will not be conducting a conference call in conjunction with this earnings release.

On May 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three months ended March 31, 2022 (Press release, Eagle Pharmaceuticals, MAY 9, 2022, View Source [SID1234613876]).

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Business and Recent Highlights:

Achieved first quarter 2022 sales of $34.3 million for vasopressin, an A-rated generic alternative to Vasostrict, which the Company began shipping on January 18, 2022, with 180 days of marketing exclusivity. U.S. sales of Vasostrict totaled $901.7 million for the 12 months ended December 31, 2021, as reported by Endo International plc.
Achieved first quarter 2022 sales of $37.2 million of PEMFEXY (pemetrexed for injection), a branded alternative to ALIMTA. PEMFEXY is a ready-to-use liquid with a unique J-code and is approved in the U.S. to treat nonsquamous non-small cell lung cancer and mesothelioma. The ALIMTA U.S. market totaled $1.2 billion for the 12 months ended December 31, 2021, as reported by Eli Lilly and Company.
As previously announced, reached agreement on the proposed terms of a transfer of the entire issued and to be issued share capital of Acacia Pharma Group plc ("Acacia") to Eagle. The transaction is expected to close in June 2022, subject to satisfaction of closing conditions. The proposed transaction is expected to provide Eagle with two currently marketed, acute care, hospital products, both of which are new chemical entities ("NCEs") with strong patent protection:
BARHEMSYS, the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting, and
BYFAVO1 indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Remains on track to support NDA filing by AOP Health Group ("AOP Health"), with whom Eagle entered into a licensing agreement in August 2021, for landiolol, a beta-1 adrenergic blocker, later this month.
Expects to start phase 2b/3 clinical trial in CAL02 patients in Q3 2022 during pneumonia season.
Reached a settlement agreement with Hospira, Inc., related to BENDEKA (bendamustine hydrochloride). Eagle had asserted two Orange Book-listed patents against Hospira related to its NDA referencing BENDEKA. The settlement agreement provides that Hospira has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances.
Anticipates strong growth for 2022; key objective to pursue additional potential transactions to continue diversifying its commercial product portfolio and pipeline.
Financial Highlights

First Quarter 2022

Total revenue for Q1 2022 was $115.9 million, compared to $41.2 million in Q1 2021, primarily reflecting strong product sales of vasopressin and PEMFEXY.
Q1 2022 net income was $44.1 million, or $3.47 per basic and $3.41 per diluted share, compared to net loss of $0.4 million, or $0.03 per basic and diluted share, in Q1 2021.
Q1 2022 adjusted non-GAAP net income* was $52.2 million, or $4.10 per basic and $4.04 per diluted share, compared to adjusted non-GAAP net income of $3.2 million, or $0.24 per basic and diluted share, in Q1 2021.
Cash and cash equivalents were $69.5 million, net accounts receivable was $130.9 million, and debt was $24.0 million as of March 31, 2022. The Company had considerable cash outlays for the launch of vasopressin and PEMFEXY and repurchased $8.1 million of the Company stock in Q1 2022.
"The early momentum we saw at the beginning of 2022 has continued to build. We posted a great first quarter, reflecting the strong initial sales of vasopressin and PEMFEXY. We continue to strengthen our cash position, expect to acquire a company with two commercial assets, and significantly diversify our product portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "Looking ahead, we plan to put our cash and balance sheet to good use as we seek to further broaden our product offerings and pipeline and to expand our presence in the acute care and oncology spaces through potential acquisitions or licensing deals," concluded Tarriff.

First Quarter 2022 Financial Results

Total revenue for the three months ended March 31, 2022, was $115.9 million, as compared to $41.2 million for the three months ended March 31, 2021. A summary of total revenue by product is outlined below:

Gross margin was 76% during the first quarter of 2022, as compared to 74% in the first quarter of 2021. The increase in gross margin for the first quarter of 2022 was driven by the benefit of launch costs recognized in prior periods.

R&D expense was $6.1 million for the first quarter of 2022, compared to $14.3 million for the first quarter of 2021. The decrease was primarily due to the non-recurrence of development cost on vasopressin and lower spend on fulvestrant and RYANODEX related projects. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense* during the first quarter of 2022 was $5.4 million.

SG&A expenses in the first quarter of 2022 totaled $22.2 million compared to $19.9 million in the first quarter of 2021. This increase was primarily related to external legal spend for the anticipated acquisition of Acacia and sales and marketing costs for the launch of PEMFEXY partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2022 adjusted non-GAAP SG&A expense* was $16.6 million.

Net income for the first quarter of 2022 was $44.1 million, or $3.47 per basic and $3.41 per diluted share, compared to net loss of $0.4 million, or $0.03 per basic and diluted share, in the first quarter of 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income* for the first quarter of 2022 was $52.2 million, or $4.10 per basic and $4.04 per diluted share, compared to adjusted non-GAAP net income* of $3.2 million, or $0.24 per basic and diluted share, in the first quarter of 2021.

2022 Full Year Expense Guidance

Adjusted non-GAAP R&D expense* is expected to be in the range of $46 million to $50 million, as compared to $32.5 million in 2021.
Adjusted non-GAAP SG&A expense* is expected to be in the range of $54 million to $58 million, as compared to $54.9 million in 2021.
The guidance excludes expense for operating Acacia in the event of successful acquisition.
Liquidity

As of March 31, 2022, Eagle had $69.5 million in cash and cash equivalents plus $130.9 million in net accounts receivable, and $24.0 million in outstanding debt. Therefore, as of March 31, 2022, Eagle had net cash plus receivables of $176.4 million.

In the first quarter of 2022, Eagle repurchased $8.1 million of its common stock as part of its current $160.0 million Share Repurchase Program. From August 2016 through March 31, 2022, Eagle has repurchased $236.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its first quarter 2022 conference call as follows:

Webcast (live and replay) www.eagleus.com, under the "Investor + News" section
A replay of the conference call will be available for one week after the call’s completion by dialing 888-562-2826 (US) or 402-220-7355 (International) and entering conference call ID EGRXQ122. The webcast will be archived for 30 days at the aforementioned URL.