On May 11, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported its financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Immunocore, MAY 11, 2022, View Source [SID1234614225]).

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Bahija Jallal, Chief Executive Officer of Immunocore, said: "This has been an exciting start to the year for Immunocore, during which we have continued to establish ourselves as a pioneer in TCR therapeutics. Our gp100 and CD3 targeting ImmTAC, KIMMTRAK, the first in this new class of TCR treatments for cancer and other diseases, has now received regulatory approval for the treatment of unresectable or metastatic uveal melanoma in the United States and European Union. We look forward later this year to exploring KIMMTRAK in cutaneous melanoma and to learning more about the broader potential of our TCR platform with data readouts from our programs targeting PRAME and MAGE."

Ralph Torbay, Head of Commercial, said: "KIMMTRAK is now approved in 30 countries globally. In the U.S., we have successfully transitioned all early access patients onto commercial product and our team is working closely with healthcare providers to change medical practice and rapidly identify new eligible patients who could benefit from KIMMTRAK. Furthermore, we were delighted that the U.S. National Comprehensive Cancer Network (NCCN) has added KIMMTRAK to the Clinical Practice Guidelines as a Category 1 treatment for unresectable or metastatic uveal melanoma, effectively positioning KIMMTRAK as a standard of care. In Europe, KIMMTRAK is now being promoted in Germany and France, and we expect launches to follow in additional priority countries."

First Quarter 2022 Highlights (including post-period)

KIMMTRAK (tebentafusp-tebn)

In January, the U.S. Food and Drug Administration (FDA) approved KIMMTRAK (tebentafusp-tebn) for the treatment of patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK is the first TCR therapeutic, the first bispecific T cell engager to treat a solid tumor, and the first and only therapy for the treatment of unresectable or mUM to receive approval from the FDA.

In February, the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or the EMA, adopted a positive opinion recommending the approval of KIMMTRAK for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM.

In March, Immunocore successfully transitioned all patients from U.S. early access program (EAP) onto commercial supply. KIMMTRAK was commercially available less than four weeks after FDA approval.

For the first quarter ended, March 31, 2022, Immunocore reported combined net KIMMTRAK and pre-product revenues of £10.5 million (or $13.8 million). U.S. net product revenue from the sale of KIMMTRAK in the first quarter was £7.7 million (or $10.1 million), this is largely due to the successful transition of patients from the EAP onto commercial supply. Pre-product revenue in France for the first quarter was £2.8 million (or $3.7 million).

In April, the EC approved KIMMTRAK (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). With this approval, KIMMTRAK has received marketing authorisation in all European Union, or EU, member states, and following completion of related national procedures, will also be eligible for sale in Iceland, Liechtenstein, and Norway. We plan to pursue regulatory approval for the marketing authorization of KIMMTRAK in all 27 member states of the EU. Following the approval of KIMMTRAK in the EU, the Company plans to transition patients from the early access programs. There are currently over 130 patients on EAP in the EU and UK.

In April, KIMMTRAK was added as a recommended Category 1 treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for metastatic uveal melanoma (mUM). NCCN publishes evidence-based guidelines that are followed by many healthcare professionals in the U.S. and globally.

In May, the Company began the commercial launch of KIMMTRAK in Germany. The company has begun transitioning patients from the EAP onto commercial supply and enabling the identification of new patients.

Anticipated Upcoming Milestones

KIMMTRAK

Q4 2022 – start randomized clinical trial in metastatic cutaneous melanoma (mCM)
ImmTAC pipeline

Q3 2022 – report initial data from IMC-F106C (PRAME) Phase 1 trial in multiple solid tumors
Q4 2022 – report complete data from IMC-C103C (MAGE-A4) Phase 1 trial in multiple solid tumors and initial data from ovarian expansion arm
ImmTAV pipeline

Q2 2022 – dose first patient in IMC-M113V Phase 1 study in HIV
Financial Results

Basic and diluted loss per share was £0.37 (or $0.48) for the three months ended March 31, 2022 compared to £0.76 for the three months ended March 31, 2021. Total operating loss for the three months ended March 31, 2022 was £16.5 million (or $21.6 million) compared to £31.9 million for the same period last year.

Total revenue for the three months ended March 31, 2022 was £22.5 million (or $29.6 million), as compared to £8.3 million for the three months ended March 31, 2021. Revenue in the three months ended March 31, 2022 consisted of net product revenue from the sale of KIMMTRAK in the United States, net pre-product revenue under a compassionate use and an early access program in France, and collaboration revenue. Revenue in the three months ended March 31, 2021 was generated solely from the Group’s collaborations.

Net product revenue from the sale of KIMMTRAK in the three months ended March 31, 2022 was £7.7 million (or $10.1 million) following FDA approval in January 2022. This is largely due to the successful transition of patients from the EAP in the U.S. to commercial supply. Net pre-product revenue for the first quarter was £2.8 million (or $3.7 million). Collaboration revenue increased by £3.7 million to £12.0 million (or $15.7 million) in the three months ended March 31, 2022 compared to £8.3 million for the three months ended March 31, 2021, primarily due to the recognition of remaining revenue under the Lilly Collaboration following termination of the agreement in the three months ended March 31, 2022.

For the three months ended March 31, 2022, our research and development ("R&D") expenses were £18.6 million (or $24.4 million), respectively, as compared to £19.9 million for the three months ended March 31, 2021. The reduction was driven by lower R&D costs incurred in relation to tebentafusp following the launch of KIMMTRAK.

For the three months ended March 31, 2022, our administrative expenses were £20.1 million (or $26.4 million), respectively, compared to £20.2 million for the three months ended March 31, 2021.

Cash and cash equivalents were £205.9 million or approximately $270.7 million as of March 31, 2022 compared to £237.9 million as of December 31, 2021.

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About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

Please see full Prescribing Information, including BOXED WARNING for CRS.

About KIMMTRAKConnect
Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

On May 11, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, will participate in a panel discussion on targeted oncology at Citi’s Biopharma Virtual Co-Panel Day on Wednesday, May 18, 2022 at 1:30 p.m. ET (Press release, Syndax, MAY 11, 2022, View Source [SID1234614224]).

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A live webcast of the panel can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On May 11, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, reported the Company will submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy candidate Procel directly to the FDA in the second half of 2022 (Press release, Kiromic, MAY 11, 2022, View Source [SID1234614223]).

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Over the course of the last ten months, the Company has developed a solid plan to address the previously outlined chemistry, manufacturing, and control (CMC) issues cited in the FDA’s July 2021 letter regarding the clinical hold on the Company’s INDs. Based on the unanimous advice from independent regulatory experts, the Company has determined that it is not necessary to proceed with the previously contemplated Type A meeting with the FDA to further address the CMC issues and instead will move forward with a submission of an amended IND for Procel directly to the FDA during the second half of this year.

The Company also announces ongoing progress toward the implementation of a current good manufacturing practice (cGMP) mammalian master cell bank (mMCB), which will provide a GMP-grade retroviral vector for gamma delta T (GDT) cell engineering. A cGMP mammalian master cell bank is a significant step forward in the Company’s clinical pathway and would address a key issue identified by the FDA in the clinical hold letter.

"We are very pleased to share these significant regulatory updates, reflecting the progress we have been making as a Company. In addition, progress toward establishing the master cell bank will enable us to create the GMP-grade retroviral vector for gamma delta cell engineering – a cornerstone of our clinical program" stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "These achievements demonstrate our team’s execution efforts toward our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate Procel by the end of the fourth quarter of 2022."

On May 11, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the first quarter ended April 2, 2022 (Press release, Perrigo Company, MAY 11, 2022, View Source,-RAISES-GUIDANCE [SID1234614222]). All comparisons are against the prior year fiscal first quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "We delivered another quarter of very strong organic net sales growth as consumer demand driven sales again strengthened sequentially. The categories in which we compete are growing and remain on-trend, and the products in our portfolio that were most disrupted by the pandemic, including cough/cold, have rebounded. The strong performance of our U.S. infant formula business, which benefited from innovation and availability while a competitor experienced quality issues, was also notable."

Kessler continued, "First quarter earnings were in-line with our expectations, despite significant and increasing cost headwinds and a significantly strengthening U.S. dollar. We now expect full year 2022 cost headwinds to increase by approximately $125 million versus prior year as compared to our original expectation of an increase of $80 million. While price increases and procurement actions are expected to offset inflation for the full year, adverse foreign exchange rate movements and to a lesser extent business disruption in Ukraine and Russia are likely to remain. With the addition of HRA Pharma and higher expectations for organic net sales growth, we expect to more than offset these headwinds and have raised our net sales and adjusted EPS guidance for the year."

Kessler concluded, "With our consumer self-care transformation complete, our focus going forward will be to ‘Optimize and Accelerate’ through gross margin enhancement via supply chain reinvention, pricing actions and portfolio consolidation, the successful integration of HRA and by continually improving our organization and culture. The path ahead is clear and we remain on track to deliver significant profitable growth over the next few years."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

First Quarter 2022 Perrigo Results from Continuing Operations

Perrigo net sales for the first quarter were $1.1 billion, an increase of $65 million, or 6.4%. Organic net sales grew 9.7%.

Net sales were driven by 1) higher incidences of cough/cold and flu-like illnesses globally, leading to an increase of $49 million in cough/cold sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 2) strong growth in U.S. Nutrition stemming from store brand infant formula share gains and a competitor recall, 3) the addition of $33 million in contract manufacturing sales to the divested RX business, 4) higher net sales in the CSCI Skincare and Personal Hygiene category, and 5) increased pricing across both Consumer Self-Care segments. These drivers also benefited from new product sales and e-commerce growth. These increases were partially offset by 1) lower net sales in the global Healthy Lifestyle and CSCI VMS categories, 2) unfavorable currency exchange rate movements of $34 million, and lower sales in Ukraine and Russia.

First quarter reported operating income was $22 million in 2022, compared to $51 million in 2021. Adjusted operating income decreased $32 million, or 26.8%, to $87 million in 2022 driven by 1) $34 million in cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, 3) higher planned advertising and promotion investments to support brand growth, 4) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year, and 5) the impact from lower sales in Ukraine and Russia. These factors were partially offset by higher gross profit flow-through resulting from higher volumes and pricing.

Reported net loss was $1.3 million, or $0.01 per diluted share, compared to reported net income of $2.8 million, or $0.02 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2022 adjusted net income was $45 million, or $0.33 per diluted share, compared to $67 million, or $0.50 per diluted share, last year. Currency-neutral EPS for the quarter was $0.37, including a $0.02 per share negative impact from the war in Ukraine.

First Quarter 2022 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA first quarter net sales of $710 million increased $70 million, or 10.9%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $153 million increased 28.8% due primarily to higher incidences of cough/cold and flu-like illnesses that led to strong demand for cough/cold products, particularly store brand liquid-based cough/cold offerings, and demand for oral allergy products.

Digestive Health
Net sales of $119 million increased 0.2% as growth in e-commerce was offset by temporary packaging constraints on a specific product, which is expected to alleviate during the second half of 2022, and lower category consumption of proton pump inhibitors compared to the prior year.

Pain & Sleep-Aids
Net sales of $103 million increased 8.2% due primarily to strong demand for children’s analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, partially offset by higher demand for certain premium dosage forms where the Company today does not provide a store brand offering.

Nutrition
Net sales of $127 million increased 38.0% due primarily to strong growth in U.S. store brand infant formula stemming from share gains and a competitor recall, new product launches within infant formula and continued growth in the oral electrolytes business.

Oral Care
Net sales of $70 million decreased 6.1% due primarily to delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $68 million decreased 11.1% due primarily to the discontinuation of diabetes products and lower category consumption and share of certain smoking cessation products.

Skincare & Personal Hygiene
Net sales of $49 million decreased 12.3% due primarily to service challenges related to the now divested Scaraway(R) brand and discontinued product in non-strategic category segments.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $21 million increased 132.6% due primarily to contract manufacturing sales to the divested RX business.

Reported operating income was $79 million in the quarter compared to $96 million in 2021. Adjusted operating income decreased $23 million to $87 million driven primarily by 1) cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, and 3) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year. These factors were partially offset by higher gross profit flow-through resulting from net sales growth and lower operating expenses.

Consumer Self-Care International Segment

CSCI net sales of $365 million decreased $5 million, or 1.4%, including a negative impact of 9.1 percentage points from unfavorable currency exchange rate movements. Organic net sales growth was a strong 7.7%. Primary category drivers are provided below.

Skincare & Personal Hygiene
Net sales of $102 million decreased 4.8%, or an increase of 4.9% excluding the impact of currency, driven primarily by increased net sales of the anti-parasite brand Paranix, due to the easing of COVID-19-related restrictions, and strong performances and new product launches in the ACO and Sebamed skincare lines.

Upper Respiratory
Net sales of $61 million increased 43.1%, or 56.6% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses led to strong demand for cough/cold products, including Bronchonolo, Coldrex, Phytosun, Physiomer and U.K. store brands. New products also contributed to growth in the quarter.

VMS
Net sales of $48 million decreased 18.8%, or 10.5% excluding the impact of currency, due primarily to lower category consumption and the lingering impact from the third quarter 2021 recall of certain batches of Davitamon and Abtei.

Pain & Sleep-Aids
Net sales of $52 million increased 5.5%, or 13.5% excluding the impact of currency, due primarily to an increase in U.K. store brand consumption and higher demand for Solpadeine, a paracetamol-based analgesics product.

Healthy Lifestyle
Net sales of $43 million decreased 15.1%, or 7.6% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption and timing of NiQuitin smoking cessation product sales to customers.

Oral Care
Net sales of $24 million decreased 4.3% or an increase of 5.5% excluding the impact of currency, due primarily to customer restocking following supply constraints in the prior year.

Digestive Health and Other
Net sales of $35 million decreased 3.6%, or an increase of 3.1% excluding the impact of currency, due primarily to higher sales of distribution brands.

Reported operating income was $16 million in the quarter compared to $17 million in the prior year quarter. Adjusted operating income decreased $7 million, or 12.1%, to $53 million as higher gross profit flow-through resulting from net sales growth was more than offset by higher planned advertising & promotion investments to support brand growth and unfavorable currency exchange rate movements. Excluding the impact of currency, adjusted operating income was flat compared to the prior year quarter.

Updated Fiscal 2022 Outlook

Based on current foreign exchange rates, the Company is raising its fiscal 2022 growth range outlook from 3.5%-4.5% to 8.5%-9.5% versus the prior fiscal year, primarily due to the acquisition of HRA, which closed on April 29, 2022. The Company is also raising its fiscal 2022 organic growth range outlook from 7%-8% to 8%-9%.

The Company is raising its adjusted diluted EPS range from $2.10-$2.30 to $2.30-$2.40, reflecting approximately $0.35 from the HRA acquisition, partially offset by approximately $0.10 from additional unfavorable exchange rate movements, $0.05 from stopping distribution of product to Russia, and approximately $0.05 in higher interest expense from refinancing.

The Company continues to expect first half margin compression and second half margin expansion and an adjusted effective tax rate of approximately 23%. Cash flow from operations as a percentage of adjusted net income is now expected to be above the Company’s original range of 95%-105%.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2022 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

On May 11, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for first quarter ended March 31, 2022 and provided a corporate update (Press release, Biodesix, MAY 11, 2022, View Source [SID1234614221]).

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"We are pleased by the progress we continue to make with our core lung diagnostic sales revenue, which grew 17% over the first quarter 2021 despite significant disruption from the COVID-19 Omicron variant during the first half of the quarter," said Scott Hutton, CEO of Biodesix. "We recovered quickly from the Omicron wave, and March was an all-time high in core lung diagnostic test results delivered. We also added to our therapeutic guidance portfolio with a full commercial launch of the 72-hour blood based GeneStrat NGS test, introducing flexibility in addressing individual patient and physician needs when considering the most appropriate treatment options for cancer. In addition, we successfully executed several strategic fundraising efforts to further support our growth and recovery resulting in an additional $27.4 million in debt and equity funding subsequent to quarter end, including a restructuring of our milestone payments to Integrated Diagnostics to provide further financial flexibility."

First Quarter 2022 Financial Results

For the three-month period ended March 31, 2022, as compared to the same period of 2021 (where applicable):

Total revenue of $6.5 million, an expected decrease of 77%, driven primarily by an expected year-over-year decline in COVID-19 diagnostic testing due to lower rate of testing compared to the first quarter of 2021:

Core lung diagnostic revenue of $4.6 million, an increase of 17% driven primarily by growth in the Nodify lung nodule management tests;

COVID-19 testing revenue of $1.0 million, a decrease of 96% in line with expectations as the pandemic recedes and COVID testing trends continue to move to at-home testing;

BioPharma Services revenue of $0.9 million, a decrease of 45% driven by disruptions in clinical trials world-wide by the spike in the Omicron COVID-19 variant;

First quarter 2022 gross margin of $3.3 million, or 51% as a percentage of revenue as compared to 37% in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing partially offset by costs related to the commercial launch of our GeneStrat NGS test in January;

Operating expenses (excluding direct costs and expenses) of $17.8 million, an increase of 10% driven primarily by growth in sales and marketing to fund our growth in sales and recent GeneStrat NGS commercial launch;

Includes non-cash stock compensation expense of $1.3 million as compared to $1.8 million in the prior year quarter;

Net loss of $15.6 million, an increase of 124%;

Cash and cash equivalents of $16.4 million as of March 31;

Included payment of $4.625 million for scheduled milestone payment in January 2022 to Integrated Diagnostics (Indi);

Liquidity and capital improvements subsequent to March 31, 2022:

Equity proceeds of $11.7 million from a private placement;

Equity proceeds of approximately $2.7 million through the at-the-market facility;

Completion of $25.0 million debt facility of which $15.0 million (approximately $13.0 million, net, after deducting estimated debt issuance costs and original issue discounts) funded in May 2022 and remaining amount contingently available based on contract terms;

Repayment of $3.0 million in outstanding principal balance on Term Loan;

Restructuring of Indi milestone payments reducing required payments by approximately $7.5 million and $7.2 million in 2022 and 2023, respectively.
2022 Financial Outlook

The Company reaffirms our 2022 financial outlook and expects to generate between $37.5 million and $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, May 11, 2022 at 8:00 a.m. Eastern Time.