On August 4, 2022 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2022 (Press release, Amgen, AUG 4, 2022, View Source [SID1234617528]). Key results include:

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Total revenues increased 1% to $6.6 billion in comparison to the second quarter of 2021, resulting from 3% growth in global product sales partially offset by lower Other Revenue from our COVID-19 manufacturing collaboration.
Volumes grew double-digits for a number of products including Repatha (evolocumab), Prolia (denosumab), LUMAKRAS/LUMYKRAS (sotorasib) and EVENITY (romosozumab-aqqg).
GAAP earnings per share (EPS) increased from $0.81 to $2.45 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired In-Process Research & Development (Acquired IPR&D) associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022, partially offset by an impairment charge related to the divestiture of GENSENTA, a generics subsidiary in Turkey.
GAAP operating income increased from $0.8 billion to $2.2 billion, and GAAP operating margin increased 21.1 percentage points to 34.6%.
Non-GAAP EPS increased from $1.77 to $4.65 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired IPR&D associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022.
Non-GAAP operating income increased from $1.6 billion to $3.3 billion, and non-GAAP operating margin increased 26.8 percentage points to 53.1%.
The Company generated $1.7 billion of free cash flow for the second quarter versus $1.7 billion in the second quarter of 2021.
2022 total revenues guidance revised to $25.5-$26.4 billion; EPS guidance revised to $11.01-$12.15 on a GAAP basis, and reaffirmed at $17.00-$18.00 on a non-GAAP basis.
"We are focused on delivering our long-term objectives by serving an ever-increasing number of patients around the world with our medicines," said Robert A. Bradway, chairman and chief executive officer. "We are advancing our pipeline and look forward to important readouts over the next few months."

Non-GAAP EPS has been recast due to an update to our non-GAAP policy effective January 1, 2022, resulting in a $2.61 reduction of previously-reported non-GAAP EPS for the second quarter of 2021. Refer to Non-GAAP Financial Measures below for further discussion.

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Beginning January 1, 2022, the Company’s non-GAAP financial measures no longer exclude adjustments for upfront license fees, development milestones and IPR&D expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions. For purposes of comparability, the non-GAAP financial results for the second quarter of 2021 have been updated to reflect this change. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

Total product sales increased 3% for the second quarter of 2022 versus the second quarter of 2021. Unit volumes grew 10%, partially offset by 6% lower net selling price and 2% negative impact from foreign exchange.

General Medicine

Prolia sales increased 13% year-over-year for the second quarter, primarily driven by 12% volume growth.
EVENITY sales increased 46% year-over-year to a record $191 million for the second quarter, driven by strong volume growth across our markets. U.S. sales grew 65% year-over-year, driven by 60% volume growth. Outside the U.S., EVENITY sales grew 17%, driven by 37% volume growth, partially offset by foreign exchange impact.
Repatha sales increased 14% year-over-year for the second quarter, driven by 55% volume growth, partially offset by lower net selling price. In the U.S., sales grew 8%, driven by 38% volume growth, partially offset by lower net selling price resulting from higher rebates to support and expand access for patients. Outside the U.S., sales grew 20%. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 1.1 million patients treated since launch.
Aimovig (erenumab-aooe) sales increased 12% year-over-year for the second quarter, primarily driven by higher net selling price, partially offset by a 11% decline in volume.
Inflammation

TEZSPIRE (tezepelumab-ekko) generated $29 million of sales in the second quarter, driven by strong adoption by both allergists and pulmonologists across all severe asthma patient types. Healthcare providers acknowledge TEZSPIRE’s unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled or biologic eligible, without any phenotypic and biomarker limitation.
Otezla (apremilast) sales increased 11% year-over-year for the second quarter, driven by 8% volume growth and favorable changes to estimated sales deductions, partially offset by lower net selling price. In the U.S., total prescription (TRx) volumes grew 12% year-over-year and new-to-brand prescriptions (NBRx) grew 18% year-over-year, supported by broader adoption of Otezla among patients with mild-to-moderate psoriasis. We expect continued volume growth in the second half of 2022 given our unique, broad indication to treat patients suffering from mild, moderate or severe psoriasis.
Enbrel (etanercept) sales decreased 8% year-over-year for the second quarter, primarily driven by lower net selling price and a 3% decline in volume. Going forward, we expect net selling price to continue to decline year-over-year, driven by increased competition.
AMGEVITA (adalimumab) sales increased 8% year-over-year for the second quarter, driven by 32% volume growth, partially offset by foreign exchange impact and lower net selling price resulting from increased competition. AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.
Hematology-Oncology

LUMAKRAS/LUMYKRAS (sotorasib) generated $77 million of sales for the second quarter, representing 24% quarter-over-quarter growth. In the U.S., LUMAKRAS has been prescribed to over 3,000 patients by over 1,900 physicians in both academic and community settings. Outside the U.S., LUMYKRAS has now been approved in over 40 countries around the world. We are actively launching in 25 markets and pursuing reimbursement in the remaining countries.
KYPROLIS (carfilzomib) sales increased 13% year-over-year for the second quarter, driven by 19% volume growth, partially offset by lower net selling price.
XGEVA (denosumab) sales increased 9% year-over-year for the second quarter, driven by higher net selling price and favorable changes to estimated sales deductions. Volume remained flat year-over-year in the second quarter.
Vectibix (panitumumab) sales decreased 13% year-over-year for the second quarter driven by the timing of shipments to Takeda, our partner in Japan, in the second quarter of 2021. In the U.S., sales increased 4% year-over-year, driven by volume growth.
Nplate (romiplostim) sales increased 16% year-over-year for the second quarter, primarily driven by 11% volume growth and higher net selling price.
BLINCYTO (blinatumomab) sales increased 29% year-over-year for the second quarter, driven by volume growth.
MVASI sales decreased 17% year-over-year for the second quarter, driven by lower net selling price that was partially offset by 10% volume growth. In the U.S., MVASI continued to hold leading volume share with 49% of the bevacizumab segment for the quarter. The most recently published Average Selling Price (ASP) for MVASI in the U.S. declined 39% year-over-year and 21% quarter-over-quarter. Looking forward, we expect continued net selling price erosion and declining volume driven by increased competition and continued ASP erosion.
KANJINTI (trastuzumab-anns) sales decreased 46% year-over-year for the second quarter, primarily driven by declines in net selling price and volume. In the U.S., KANJINTI continued to hold leading volume share with 41% of the trastuzumab segment in the quarter. The most recently published ASP for KANJINTI in the U.S. declined 43% year-over-year and 21% quarter-over-quarter. Going forward, we expect continued net selling price deterioration and volume declines driven by increased competition and continued ASP erosion.
Established Products

Total sales of our established products, which include Neulasta (pegfilgrastim), NEUPOGEN (filgrastim), EPOGEN (epoetin alfa), Aranesp (darbepotein alfa), Parsabiv (etelcalcetide), and Sensipar/Mimpara (cinacalcet), decreased 15% year-over-year for the second quarter, primarily driven by lower net selling price. In the second quarter, the published ASP for Neulasta in the U.S. declined 35% year-over-year and 9% quarter-over-quarter. In the aggregate, we expect the year-over-year net selling price and volume erosion for this portfolio of products to continue.
Product Sales Detail by Product and Geographic Region

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses decreased 22%. Cost of Sales margin decreased 2.8 percentage points primarily driven by lower COVID-19 antibody shipments and lower manufacturing costs, partially offset by unfavorable product mix. Research & Development (R&D) expenses decreased 4% primarily due to lower marketed product support, partially offset by higher spend in research and early pipeline. Acquired IPR&D expenses were zero in Q2 2022, compared to $1.5 billion in Q2 2021 due to the Five Prime Therapeutics acquisition. Selling, General & Administrative (SG&A) expenses decreased 4%. R&D and SG&A expenses were also impacted by lower acquisition-related expenses from Five Prime Therapeutics.
Operating Margin as a percentage of product sales increased 21.1 percentage points to 34.6%.
Tax Rate decreased 2.8 percentage points primarily due to the Five Prime Therapeutics non-deductible IPR&D expense in the prior year, partially offset by the impact of current year net unfavorable items, including an increase in the interest expense on tax reserves and the tax impact of the GENSENTA impairment charge.
On a non-GAAP basis:

Total Operating Expenses decreased 34%. Cost of Sales margin decreased 2.2 percentage points primarily driven by lower COVID-19 antibody shipments and lower manufacturing costs, partially offset by unfavorable product mix. R&D expenses decreased 2% primarily due to lower marketed product support, partially offset by higher spend in research and early pipeline. Acquired IPR&D expenses were zero in Q2 2022, compared to $1.5 billion in Q2 2021 due to the Five Prime Therapeutics acquisition. SG&A expenses decreased 2%.
Operating Margin as a percentage of product sales increased 26.8 percentage points to 53.1%.
Tax Rate decreased 11.6 percentage points primarily due to the Five Prime Therapeutics non-deductible IPR&D expense in the prior year.
Cash Flow and Balance Sheet

The Company generated $1.7 billion of free cash flow in the second quarter of 2022 versus $1.7 billion in the second quarter of 2021.
The Company’s second quarter 2022 dividend of $1.94 per share was declared on March 2, 2022, and was paid on June 8, 2022, to all stockholders of record as of May 17, 2022, representing a 10% increase from 2021.
During the second quarter, there were no repurchases of shares of common stock, following the 24.6 million shares of common stock repurchased in the first quarter primarily in connection with accelerated share repurchase agreements that the Company entered into in February 2022.
Cash and investments totaled $7.2 billion and debt outstanding totaled $36.5 billion as of June 30, 2022.
2022 Guidance

For the full year 2022, the Company now expects:

Total revenues in the range of $25.5 billion to $26.4 billion.
On a GAAP basis, EPS in the range of $11.01 to $12.15 and a tax rate in the range of 11.5% to 13.0%.
On a non-GAAP basis, EPS in the range of $17.00 to $18.00, unchanged from previous guidance, and a tax rate in the range of 14.0% to 15.0%.
Capital expenditures to be approximately $950 million, unchanged from previous guidance.
Share repurchases in the range of $6.0 billion to $7.0 billion, unchanged from previous guidance.
Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

Inflammation

Otezla

The primary and secondary endpoints of the SPROUT study, an international Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating Otezla in pediatric patients (ages 6 through 17) with moderate to severe pediatric plaque psoriasis, have been successfully met. No new safety signals were identified and the overall treatment-emergent adverse event profile during the placebo-controlled phase of the study was consistent with the known safety profile of Otezla. The trial will continue to completion and final analysis, expected in 2023.
TEZSPIRE

In July, TEZSPIRE was recommended for approval in the European Union by the Committee for Medicinal Products for Human Use for severe asthma.
In July, Health Canada approved TEZSPIRE for the add-on maintenance treatment of adult and adolescents 12 years and older with severe asthma,
In July, the Brazilian National Health Surveillance Agency (ANVISA) approved TEZSPIRE as an add-on maintenance treatment in patients with severe asthma aged 12 years and older. Regulatory reviews continue in other jurisdictions.
The PASSAGE Phase 4 real-world effectiveness study and the WAYFINDER Phase 3b study are enrolling patients with severe asthma.
The SUNRISE Phase 3 study, designed to assess the efficacy and safety of TEZSPIRE in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma, was initiated.
A Phase 3 study continues to enroll patients with chronic rhinosinusitis with nasal polyps.
Planning is underway for a Phase 3 study in patients with eosinophilic esophagitis.
A Phase 2b study in patients with chronic spontaneous urticaria is fully enrolled with data readout anticipated in H1-2023.
A Phase 2 study continues to enroll patients with chronic obstructive pulmonary disease.
Rocatinlimab (AMG 451 / KHK4083)

The ROCKET Phase 3 program evaluating rocatinlimab, an anti-OX40 monoclonal antibody, in patients with moderate to severe atopic dermatitis was initiated in June. Following additional discussions with regulators and our partner, we are amending the studies to further improve patient convenience and investigate a range of doses. No safety or efficacy issues have arisen.
Rozibafusp alfa (AMG 570)

A Phase 2b study of rozibafusp alfa, an antibody-peptide conjugate that simultaneously blocks inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) activity, continues to enroll patients with systemic lupus erythematosus (SLE).
Efavaleukin alfa (AMG 592)

A Phase 2b study of efavaleukin alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, continues to enroll patients with SLE while a Phase 2b study continues to enroll patients with ulcerative colitis.
Ordesekimab (AMG 714 / PRV-015)

A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, continues to enroll patients with non-responsive celiac disease.
Oncology

LUMAKRAS/LUMYKRAS

In June, data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting where investigators evaluated patterns of resistance to LUMAKRAS in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) at disease progression. These and other data continue to guide the LUMAKRAS clinical development program.
The Company is planning to initiate a Phase 3 study of LUMAKRAS plus chemotherapy in first-line KRAS G12C mutant and PD-L1 negative advanced / metastatic NSCLC.
Initial data from cohorts exploring LUMAKRAS in combination with immunotherapy in patients with KRAS G12C-mutated NSCLC will be presented on August 7th at the International Association for the Study of Lung Cancer World Conference on Lung Cancer (WCLC).
Initial data from cohorts exploring LUMAKRAS in combination with the Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2) inhibitor RMC-4630 from Revolution Medicines in patients with KRAS G12C-mutated NSCLC will be presented on August 7th at WCLC. This combination was safe and well tolerated, with promising and durable clinical activity in patients with NSCLC, most notably in those who were KRAS G12C inhibitor-naïve.
Top-line results from the event-driven, confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in Q3-2022.
Top-line results from a study comparing the 960 mg/day dose of LUMAKRAS with a lower dose of 240 mg/day in patients with KRAS G12C-mutated advanced NSCLC are expected in Q4-2022.
A Phase 2 study in first-line patients with KRAS G12C-mutated NSCLC whose tumors express serine/threonine kinase 11 (STK11) mutations and/or less than 1% programmed death-ligand 1 is ongoing.
A Phase 3 study of LUMAKRAS in combination with Vectibix in third-line KRAS G12C-mutated CRC continues to enroll.
Data from the full dose expansion Phase 1b study of LUMAKRAS in combination with Vectibix in refractory KRAS G12C-mutated CRC were accepted for presentation at the European Society for Medical Oncology Congress taking place in September.
Vectibix

In June, the Company and its partner Takeda Pharmaceutical Company presented data from the Phase 3 PARADIGM clinical trial of Vectibix in Japanese patients with previously untreated unresectable wild-type RAS metastatic CRC at the ASCO (Free ASCO Whitepaper) annual meeting. These data demonstrated that the mFOLFOX6 + Vectibix combination provides a statistically significant improvement in overall survival over the mFOLFOX6 + bevacizumab combination in patients with a left-sided primary tumor or regardless of tumor locations.
Bemarituzumab

The final analysis of the FIGHT study, a Phase 2 randomized, double-blind, controlled study evaluating bemarituzumab, a fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, and modified FOLFOX6 in patients with previously untreated advanced gastric and gastroesophageal junction cancer was completed. These results continued to demonstrate that bemarituzumab + mFOLFOX6 improves the clinical outcome of patients with FGFR2b expressing tumors with no new safety concerns. A greater survival benefit was observed with increasing FGFR2b expression levels.
A Phase 3 study (FORTITUDE-101) of bemarituzumab plus chemotherapy, versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression continues to enroll patients.
A Phase 1b/3 study (FORTITUDE-102) of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer with FGFR2b overexpression is enrolling patients in the Phase 3 portion of the study.
A Phase 1b study (FORTITUDE-103) of bemarituzumab plus oral chemotherapy regimens in first-line gastric cancer with FGFR2b overexpression is enrolling patients.
A Phase 1b study (FORTITUDE-201) of bemarituzumab monotherapy and in combination with docetaxel continues to enroll patients with squamous NSCLC with FGFR2b overexpression.
A Phase 1b/2 study (FORTITUDE-301), evaluating the safety and efficacy of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, was initiated.
Tarlatamab (AMG 757)

Updated exploration and first expansion Phase 1 data of tarlatamab, a half-life extended (HLE) bi-specific T-cell engager (BiTE) molecule targeting delta-like ligand 3 (DLL3), in heavily pretreated patients with relapsed/refractory small cell lung cancer (SCLC) will be presented on Aug 8th at WCLC. In this setting, tarlatamab demonstrated promising antitumor activity with notable response durability.
DeLLphi-301, a potentially registrational Phase 2 study of tarlatamab for the treatment of relapsed/refractory SCLC after two or more prior lines of treatment, continues to enroll patients.
DeLLphi-302, a Phase 1b study of tarlatamab in combination with AMG 404, an anti-programmed cell death-1 monoclonal antibody, continues to enroll patients with second-line or later SCLC.
DeLLphi-303, a Phase 1b study of tarlatamab in combination with standard of care in first-line SCLC, is open for enrollment.
DelLphi-300, a Phase 1b study of tarlatamab, continues to enroll patients with de novo or treatment emergent neuroendocrine prostate cancer.
AMG 509

A Phase 1 dose-escalation study of AMG 509, a bi-specific molecule targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) continues to enroll patients with metastatic castrate-resistant prostate cancer (mCRPC).
AMG 340

A Phase 1 dose-escalation study of AMG 340, a lower T-cell affinity BiTE molecule targeting prostate-specific membrane antigen (PSMA), continues to enroll patients with mCRPC.
Acapatamab (AMG 160)

Acapatamab, a HLEBiTE molecule targeting PSMA for the treatment of patients with mCRPC, has been deprioritized in favor of AMG 340.
Pavurutamab (AMG 701)

Clinical development of pavurutamab an anti-B-cell maturation antigen (BCMA) HLE BiTE molecule being investigated for the treatment of multiple myeloma, has been discontinued for strategic reasons.
AMG 193

A Phase 1/1b/2 study of AMG 193, a novel small molecule methylthioadenosine (MTA) cooperative protein arginine methyltransferase 5 (PRMT5) molecular glue, continues to enroll patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
General Medicine

Repatha

An abstract based on data from the Repatha open label extension (OLE) studies (FOURIER OLE) has been accepted as a late-breaking presentation for the European Society of Cardiology (ESC) annual conference in August.
Olpasiran (AMG 890)

In May, the Company announced positive top-line data from a Phase 2 study of olpasiran, a lipoprotein(a) (Lp(a)) small interfering RNA molecule, in subjects with elevated Lp(a). These data demonstrated a significant reduction from baseline in Lp(a) of up to or greater than 90 percent at week 36 (primary endpoint) and week 48 (end of treatment period) for the majority of doses. No new safety concerns were identified during this treatment period. Presentation of these results is expected at a medical congress in 2022.
AMG 133

A Phase 1 study of AMG 133, a multispecific that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon-like peptide 1 (GLP-1) receptor, has completed enrollment.
Data from the initial cohorts of this Phase 1 study will be submitted to a medical congress occurring in Q4-2022.
Biosimilars

The final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis is expected in 2022.
A Phase 3 study to support an interchangeability designation in the U.S. for ABP 654 is ongoing.
Phase 3 studies of ABP 938, an investigational biosimilar to EYLEA (aflibercept), and ABP 959, an investigational biosimilar to SOLIRIS (eculizumab), are on track, with data expected in 2022.
A Phase 3 study to support an interchangeability designation in the U.S. for AMJEVITA (adalimumab-atto) is ongoing.
The U.S. label for AMJEVITA has been modified to include pediatric Crohn’s disease (ages 6 and above) and juvenile idiopathic arthritis (ages 2-3).
TEZSPIRE is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451 / KHK4083 is being developed in collaboration with Kyowa Kirin.
Ordesekimab formerly AMG 714 and also known as PRV-015 is being developed in collaboration with Provention Bio.
AMG 509 is being developed in collaboration with Xencor.
STELARA is a registered trademark of Janssen Pharmaceutica NV.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the second quarters of 2022 and 2021, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2022 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Beginning January 1, 2022, following industry guidance from the U.S. Securities and Exchange Commission, the Company no longer excludes adjustments for upfront license fees, development milestones and IPR&D expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions from its non-GAAP financial measures. For purposes of comparability, the non-GAAP financial results for the second quarter of 2021 have been updated to reflect this change. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2022 and 2021. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

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

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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

Second Quarter 2022 Financial Results

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

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

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

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

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

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

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

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

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

Financial Guidance

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

Webcast

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

Non-GAAP Financial Measures

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

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

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

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

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

Second Quarter 2022 and Recent Operational Highlights

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

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

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

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

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

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

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

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

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

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

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

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

Conference Call Information

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

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

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

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

Second Quarter INGREZZA Net Product Sales and Commercial Highlights:

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

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

Recent Events:

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

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

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

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

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

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

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

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Recent developments and highlights include:

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

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

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

Revenue

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

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

Product Gross Profit & Margin

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

Operating Expenses

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

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

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

Net Loss Attributable to Cerus Corporation

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

Non-GAAP Adjusted EBITDA

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

Balance Sheet & Cash Use

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

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

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

Reiterating 2022 Product Revenue Guidance

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

Quarterly Conference Call

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

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