On November 1, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that three abstracts highlighting the company’s unique, multi-omics immuno-oncology capabilities and offerings will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting & Pre-Conference Programs (SITC 2022), taking place November 8-12, 2022, in Boston (Press release, Veracyte, NOV 1, 2022, View Source [SID1234622700]).

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"Our comprehensive multi-omics expertise and tools have demonstrated potential to address critical questions related to the newest areas of cancer therapy, including which patients are most likely to benefit from immunotherapies," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "The abstracts being presented at SITC (Free SITC Whitepaper) 2022 will provide additional insight into how our Veracyte Biopharma Atlas and Brightplex offerings can enhance understanding of the tumor microenvironment to help our biopharma partners confidently advance every step of their oncology drug development programs."

Following are details of the Veracyte abstracts that will be shared during poster sessions at the SITC (Free SITC Whitepaper) 2022 Annual Meeting. Poster sessions will be held in the Boston Convention and Exhibition Center, Hall C.

Veracyte will also host a symposium at SITC (Free SITC Whitepaper) 2022 to provide additional detail regarding the development of the DLBCL Biopharma Atlas featured in poster 1454. The company’s Biopharma Atlas, generated through unsupervised multi-omics and multimodal assessment of thousands of parameters, may be used to generate customized maps and clusters for patient group identification and clinical outcome interpretation.

About Veracyte’s Biopharma Offerings

Veracyte collaborates with biopharma partners to provide novel insights, expertise and capabilities that empower partners to confidently advance every step of their oncology drug development programs. With an array of offerings that include the Veracyte Biopharma Atlas, Brightplex and Decipher GRID Real World Data (RWD), Veracyte helps address each partner’s unique oncology drug development needs, including therapeutics and diagnostic development, clinical development insights and decisions, clinical trial patient selection, and clinical trial management. For more information, please visit View Source

On November 1, 2022 Peptomyc reported that Researchers have found that a drug that targets the key, cancer-causing gene, MYC, has for the first time been able to inhibit the function of the gene in a phase I clinical trial (Press release, Peptomyc, NOV 1, 2022, View Source [SID1234622699]). Until now, no other drug has been able to do this safely and effectively.

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Presenting preliminary results from the trial at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) [1] Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, Dr Elena Garralda, Director of the Early Drug Development Unit at Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, and a member of the scientific committee for the meeting, said: "MYC is one of the ‘most wanted’ targets in cancer because it plays a key role in driving and maintaining many common human cancers, such as breast, prostate, lung and ovarian cancer. To date, no drug that inhibits MYC has been approved for clinical use."

Scientists from VHIO developed a mini-protein called OMO-103 that can enter cells and reach the nucleus. In experiments in the lab and in mice, they had shown that it successfully inhibited the ability of MYC to promote tumour growth by blocking MYC’s function of controlling the flow of information from many common genetic mutations found in cancer.

Starting in April 2021 Dr Garralda, in collaboration with two other Spanish sites, enrolled 22 patients to a phase I clinical trial to assess the safety of OMO-103 and to see if there were any early signs of it controlling cancer. The patients had a range of solid tumours, including pancreatic, bowel, and non-small cell lung cancers. They had all been heavily pre-treated, having received between three and 13 other treatments previously.

OMO-103 was given intravenously once a week at six dose levels ranging from 0.48 to 9.72 mg per kg of patient weight. The researchers took biopsies from the tumours at the start of the study and after three weeks of treatment to assess levels of MYC gene activity and other biological indicators for cancer.

By 10 October 2022 [2], eight out of 12 patients who had CT scans after nine weeks had stable disease, with the treatment having stopped the cancer growing. Of these, two had pancreatic cancer, three had colon cancer, one had non-small lung cancer, one had a sarcoma and one had a salivary gland cancer.

Dr Garralda said: "It’s still very early days to assess activity of the drug, but we are seeing stabilisation of disease in some patients. Remarkably, one patient with pancreatic cancer stayed on the study for over six months, his tumour shrank by eight per cent and there was a reduction in tumour-derived DNA circulating in the blood stream. The patient with a salivary gland tumour has stable disease and is still in the study after 15 months.

"The most exciting thing is that biological markers show that we are targeting MYC successfully. In addition, the adverse side effects are mostly mild, which is important when we start to think about next steps and combining OMO-103 with chemotherapy or other therapies."

The most common treatment-related adverse side effects were mild reactions to the intravenous infusion, such as chills, fever, nausea, rash and low blood pressure. Higher dose levels were associated with more reactions to the infusion but were easily treated. Inflammation of the pancreas was the only dose-limiting reaction, which occurred in one patient.

Analysis of how OMO-103 was absorbed and processed in the body indicated that it remained for at least 50 hours in blood serum.

"We have experimental evidence that this could be a significant underestimate of how long the drug remains in the tumour. Evidence from our work in mice suggest drug concentrations in the tumour that are at least four-fold higher than in the blood," said Dr Garralda. "In addition, even after long-term treatment, we could not detect any anti-drug antibodies, which can decrease the amount of drug available and therefore make it less effective."

She concluded: "OMO-103 is the first MYC inhibitor to successfully complete a phase I clinical trial and to be ready to proceed to a phase II trial. We have determined the recommended dose for phase II to be 6.48mg/kg."

Dr James L. Gulley is co-chair of the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium for the NCI and Director of the Medical Oncology Service, Center for Cancer Research, NCI, USA, and was not involved in the research. He said: "MYC plays an important role in many cell-signaling pathways that promote a range of different cancers but has long been perceived as an ‘undruggable’ target. Researchers have spent much time and energy on the search for drugs that target MYC successfully but it has proved hard to develop therapies that are effective but don’t have side effects that are too severe for patients to tolerate. These results showing that patients typically experienced mild adverse side effects to OMO-103 are important when considering next steps and how it might be combined with chemotherapy. We look forward to the results from the phase II trial with interest."

Abstract no: 7, "Dose escalation study of OMO-103, a first in class Pan-MYC-Inhibitor in patients (pts) with advanced solid tumors", Elena Garralda, presented in the ‘New drugs on the horizon’ session, 11.30-13.00 hrs CEST, Friday 28 October.

[1] EORTC [European Organisation for Research and Treatment of Cancer, NCI [National Cancer Institute], AACR (Free AACR Whitepaper) [American Association for Cancer Research]. The Symposium takes place in Barcelona from 26-28 October 2022.[2] These are the latest, updated results.

The study was funded by Peptomy-SL and by funding from the SME Instrument phase II within the EU’s Horizon 2020 programme.

On November 1, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2022 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones (Press release, Exelixis, NOV 1, 2022, View Source [SID1234622698]).

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"Exelixis focused its efforts toward the progress and expansion of our clinical and early-stage pipeline during the third quarter of 2022, fueled by the growing revenues from our cabozantinib franchise," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The team continued to drive strong commercial performance for cabozantinib, resulting in 39 percent year-over-year net product revenue growth for our flagship franchise. The team was also highly active on the business development front evaluating various opportunities and executing on multiple deals, including new option deals with Cybrexa and Sairopa announced today, which highlight our strategic efforts to access clinical- or near-clinical- stage assets that have the potential to be first- or best-in-class medicines and may provide differentiated benefits to patients with cancer."

Dr. Morrissey continued: "In addition, we achieved key clinical milestones, including presenting detailed results from our pivotal COSMIC-313 clinical trial and dose-escalation data from the phase 1b STELLAR-001 trial of XL092 at the ESMO (Free ESMO Whitepaper) 2022 Congress, as well as sharing the first clinical update from our phase 1 XB002 tissue factor ADC program at the 34th ENA Symposium in October. I’d like to thank the entire Exelixis team for their continued hard work and dedication in the third quarter as we made significant progress in commitment of the patients we serve."

Third Quarter 2022 Financial Results

Total revenues for the quarter ended September 30, 2022 were $411.7 million, as compared to $328.4 million for the comparable period in 2021.

Total revenues for the quarter ended September 30, 2022 included net product revenues of $366.5 million, as compared to $263.1 million for the comparable period in 2021. The increase in net product revenues was

primarily due to an increase in sales volume, which was partially offset by increases in discounts and allowances, primarily from an increase in chargebacks related to the 340B Drug Pricing Program.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $45.3 million for the quarter ended September 30, 2022, as compared to $65.3 million for the comparable period in 2021. The decrease in collaboration revenues was primarily related to decreases in the recognition of milestone-related revenues and development cost reimbursements earned, which was partially offset by higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda).

Research and development expenses for the quarter ended September 30, 2022 were $198.8 million, as compared to $163.4 million for the comparable period in 2021. The increase in research and development expenses were primarily related to increases in clinical trial costs, personnel expenses, consulting and outside services expenses, and stock-based compensation expense, which were partially offset by a decrease in other development costs.

Selling, general and administrative expenses for the quarter ended September 30, 2022 were $115.0 million, as compared to $101.6 million for the comparable period in 2021. The increase in selling, general and administrative expenses were primarily related to increases in personnel expenses, business technology initiatives, and rent and utilities expenses.

Provision for income taxes for the quarter ended September 30, 2022 was $18.8 million, as compared to $15.1 million for the comparable period in 2021, primarily due to an increase in pre-tax income.

GAAP net income for the quarter ended September 30, 2022 was $73.2 million, or $0.23 per share, basic and diluted, as compared to GAAP net income of $38.2 million, or $0.12 per share, basic and diluted, for the comparable period in 2021.

Non-GAAP net income for the quarter ended September 30, 2022 was $102.0 million, or $0.32 per share, basic and $0.31 per share, diluted, as compared to non-GAAP net income of $64.5 million, or $0.20 per share, basic and diluted, for the comparable period in 2021.

Cash, cash equivalents, restricted cash equivalents and investments were $2.1 billion at September 30, 2022, as compared to $1.9 billion at December 31, 2021.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance

for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2022 Financial Guidance

Exelixis is providing the following updated financial guidance for fiscal year 2022:

____________________
(1) Includes $45 million of non-cash stock-based compensation expense.
(2) Includes $60 million of non-cash stock-based compensation expense.

Cabozantinib Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $366.5 million during the third quarter of 2022, up 6% over the prior quarter, comprised of net product revenues of $361.4 million from CABOMETYX (cabozantinib) and $5.1 million from COMETRIQ (cabozantinib). In the third quarter of 2022, global cabozantinib franchise net product revenues generated by Exelixis and its partners were almost $500 million. Exelixis earned $30.3 million in royalty revenues during the quarter ended September 30, 2022, pursuant to collaboration agreements with its partners, Ipsen and Takeda.

Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Renal Cell Carcinoma (RCC) Presented at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. In September, Exelixis presented detailed results from the pivotal phase 3 COSMIC-313 trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC, at the 2022 ESMO (Free ESMO Whitepaper) Congress. The data included detailed results of the primary endpoint of progression-free survival (PFS) demonstrating a positive PFS benefit for the triplet combination of cabozantinib, nivolumab and ipilimumab compared to the combination of nivolumab and ipilimumab, as well as encouraging objective response rates in the PFS intent-to-treat population. The safety profile observed in the trial was reflective of the known safety profiles for each single agent as well as the combination regimens used in this study. Previously, in July, Exelixis announced that COSMIC-313 met its primary endpoint, demonstrating significant improvement in PFS at the primary analysis. At a prespecified interim analysis for the secondary endpoint of overall survival (OS), the combination of cabozantinib, nivolumab and ipilimumab did not demonstrate a significant benefit over the combination of nivolumab and ipilimumab. Therefore, the trial will continue to the next analysis of OS.

Pipeline Highlights

Presentation of Dose-Escalation Results from Phase 1b STELLAR-001 Trial Evaluating XL092 Monotherapy and in Combination with Atezolizumab in Patients with Advanced Solid Tumors at the 2022 ESMO (Free ESMO Whitepaper) Congress. In September, Exelixis presented results from the dose-escalation stage of STELLAR-001, an ongoing phase 1b trial evaluating XL092 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The data showed that XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile. Of note, both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population, including clear cell RCC patients previously treated with cabozantinib. Tumor reduction was seen in a majority of patients along with a high disease control rate. The maximum tolerated dose was determined to be 120 mg, and the recommended dose for the expansion stage is 100 mg for both single-agent XL092 and XL092 in combination with atezolizumab. The cohort-expansion stage of the study is currently ongoing and enrolling patients across multiple solid tumor types.

Expanded Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb (BMS) to Include Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial. In October, Exelixis announced the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with BMS to include the use of the fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial, which is evaluating XL092 in combination with multiple immune checkpoint inhibitors in advanced solid tumors. Relatlimab is a lymphocyte activation gene-3 (LAG-3)-blocking antibody. LAG-3 is an inhibitory immune checkpoint expressed on the surface of T-cells. The STELLAR-002 trial is divided into two parts: a dose-escalation stage and a cohort-expansion stage. Enrollment and dosing in the dose-escalation portion of STELLAR-002 is ongoing. The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the combination therapy regimens, including: XL092 and nivolumab; XL092, nivolumab and ipilimumab; and XL092 and the fixed-dose combination of nivolumab and relatlimab. The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.

Presentation of Initial Dose-Escalation Results from the First-in-Human Phase 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium. In October, Exelixis presented promising initial results from the ongoing dose-escalation stage of JEWEL-101, a phase 1 study evaluating Exelixis’ XB002 next-generation tissue factor-targeting antibody-drug conjugate (ADC), at the 34th ENA Symposium. The data demonstrated that XB002 was well-tolerated across multiple dose levels, with no dose-limiting toxicities observed as of the data cutoff. A pharmacokinetic analysis demonstrated that XB002 exposure increased more than or proportionately to dose increases. XB002 total antibody and intact ADC pharmacokinetics were similar, suggesting XB002 is stable after infusion. Consistent with this, levels of free circulating payload remained low at all dose levels. JEWEL-101 is enrolling patients with advanced solid tumors for which therapies are unavailable, ineffective or intolerable. The dose-escalation stage of the study is currently ongoing and will progress to the cohort-expansion stage once the recommended dose and/or maximum tolerated dose for XB002 have been determined. In the upcoming cohort-expansion stage, the efficacy of XB002 will be further evaluated as a single agent and in combination with nivolumab.

Corporate Updates

Exclusive License Agreement with Ryvu Therapeutics S.A. (Ryvu) to Develop Novel STING Agonist-Based Targeted Cancer Therapies. In July, Exelixis and Ryvu announced an exclusive license agreement focused on the development of novel targeted therapies utilizing Ryvu’s STING (STimulator of INterferon Genes) technology. The collaboration is intended to expand Exelixis’ portfolio of biotherapeutics by combining its tumor-specific

targeting approaches with Ryvu’s proprietary small molecule STING agonists and STING biology know-how. Under the terms of the agreement, Exelixis paid Ryvu an upfront fee of $3.0 million in exchange for certain rights to Ryvu’s STING agonist small molecules, which Exelixis will seek to incorporate into targeted therapies such as ADCs. Exelixis will lead all research activities and, upon selection of each development candidate, will be responsible for all development and commercialization activities. Ryvu will provide expert guidance and know-how during the early research phase of the partnership.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal period ended October 1, 2021, is indicated as being as of and for the period ended September 30, 2021.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the third quarter of 2022 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, November 1, 2022.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the
webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on Thursday, November 3, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 6992264. A webcast replay will also be archived on www.exelixis.com for one year.

On November 1, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the third quarter ended September 30, 2022 (Press release, Acorda Therapeutics, NOV 1, 2022, View Source [SID1234622697]).

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"The AMPYRA arbitration ruling was a major milestone for Acorda, providing a significant cash infusion and, even more importantly, the ability for us to obtain AMPYRA supply at far more competitive rates. We expect this to significantly enhance the value of this product to the company," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are also pleased that INBRIJA continued to recover from the impact of the pandemic surge in the first quarter of this year. Independent sources show that INBRIJA is the market leader for on-demand treatments in Parkinson’s disease, with a 67% share. Our highest priority now is to increase the size of the overall on-demand market by educating health care professionals and people with Parkinson’s about how important it is to address OFF periods."

Regarding the Special Meeting of Stockholders, Dr. Cohen added, "The board of directors and I urge all shareholders to vote FOR Proposal 2, to authorize the reverse stock split, in advance of the meeting on November 4. This is critical to ensure that we are not de-listed from Nasdaq, which could hamper our ability to execute on our business plan and could result in our being in default to our debtholders."

Third Quarter 2022 Financial Results

For the quarter ended September 30, 2022, the Company reported INBRIJA worldwide net revenue of $8.8 million, of which $7.8 million was derived from sales in the U.S., a 1% increase compared to the same quarter in 2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.0 million in the third quarter related to the Esteve launch in Germany.

For the quarter ended September 30, 2022, the Company reported AMPYRA net revenue of $21.1 million, compared to $20.0 million for the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended September 30, 2022 were $1.4 million, including negligible share-based compensation expenses, compared to $1.9 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 September 30, 2022 were $23.0 million, including $0.4 million of share-based compensation, compared to $29.6 million, including $0.6 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended September 30, 2022 was negligible, compared to $(0.3) million for the same quarter in 2021.

Provision for income taxes for the quarter ended September 30, 2022 was $1.4 million, compared to a benefit from income taxes of $3.1 million for the same quarter in 2021.

The Company reported a GAAP net loss of $13.9 million for the quarter ended September 30, 2022, or $0.57 per diluted share. GAAP net loss in the same quarter of 2021 was $27.1 million, or $2.43 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2022 was $13.3 million, or $0.55 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $15.9 million, or $1.43 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 September 30, 2022, the Company had cash, cash equivalents, and restricted cash of $34.2 million, compared to $65.2 million at year end 2021. Restricted cash includes $12.4 million in escrow related to the semi-annual interest payment to the holders of its 6.00% convertible senior secured notes (Convertible Notes). Cash at September 30, 2022 does not include the $16.5 million arbitration award, which amount was received in October 2022

Special Meeting of Stockholders November 4, 2022

Acorda will hold a Special Meeting of Stockholders on Friday, November 4 (the Special Meeting). Acorda’s CEO, board and the three leading proxy advisory firms recommend that shareholders vote FOR both of the following proposals to be addressed at the meeting:

Reverse Stock Split Proposal: To authorize Acorda’s Board of Directors to implement a reverse stock split of its common stock at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year of the Special Meeting. This proposal is critical to get Acorda’s stock price above $1.00 per share in order to avoid being delisted from Nasdaq. Delisting could put the company in default to the holders of its Convertible Notes, potentially requiring Acorda to liquidate or file for bankruptcy. In a reverse stock split, shareholders would hold the exact same percentage of Acorda stock, with the same value as they did prior to the split.

Adjournment Proposal: To approve one or more adjournments of the Special Meeting to a later date or dates, if necessary or appropriate, to solicit additional proxies if there are insufficient votes to approve the Reverse Stock Split Proposal at the time of the Special Meeting, or in the absence of a quorum.

AMPYRA Arbitration

On October 16, 2022 we announced that an arbitration panel issued a final decision in a dispute with Alkermes PLC (Nasdaq: ALKS) regarding licensing royalties relating to AMPYRA (dalfampridine). Acorda was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, Acorda will no longer have to pay Alkermes any royalties on net sales for license and supply of AMPYRA, and Acorda is now free to use alternative sources for supply of AMPYRA, which it has already secured.

2022 – 2027 Financial Guidance

For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and adjusted operating expenses to be $110 – $120 million. The financial guidance provided below includes non-GAAP projections of adjusted operating expenses (adjusted OPEX) and adjusted earnings before income taxes depreciation and amortization (adjusted EBITDA), as described below under "Non-GAAP Financial Measures."

On November 1, 2022 McKesson Corporation (NYSE:MCK) reported results for the second-quarter ended September 30, 2022 (Press release, McKesson, NOV 1, 2022, View Source [SID1234622696]).

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"Our financial results for the second quarter demonstrate how the continued development of our strategy, operating execution, and talented teams are driving solid growth. This performance enables further investments in both our oncology and biopharma businesses, which are foundations for our ability to deliver long term shareholder value," said Brian Tyler, chief executive officer. "McKesson continues to advance as a diversified healthcare services leader. Our expanding capabilities, combined with continued execution, give us the confidence in our outlook, and as a result, we are raising our guidance for fiscal 2023 Adjusted Earnings per Diluted Share to $24.45 to $24.95."

Second-quarter revenues were $70.2 billion, an increase of 5% from a year ago, primarily driven by growth in the U.S. Pharmaceutical segment, resulting from increased specialty product volumes, including retail national account customers, and market growth, partially offset by lower revenues in the International segment as a result of the progress on the planned divestiture of McKesson’s European business.

Second-quarter earnings per diluted share from continuing operations was $6.46 compared to $1.71 a year ago, an increase of $4.75.

Second-quarter Adjusted Earnings per Diluted Share was $6.06 compared to $6.15 a year ago, a decrease of 1%, driven by prior year net gains from McKesson Ventures’ equity investments and lower contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs and COVID-19 tests, partially offset by a lower share count. Second-quarter Adjusted Earnings per Diluted Share included pre-tax net losses of approximately $3 million associated with McKesson Ventures’ equity investments, compared to pre-tax net gains of approximately $97 million in the second-quarter of fiscal 2022.

For the first six months of the fiscal year, McKesson returned $1.6 billion of cash to shareholders, which included $1.5 billion of common stock repurchases and $139 million of dividend payments. During the first six months of the fiscal year, McKesson generated cash from operations of $166 million, and invested $222 million in capital expenditures, resulting in negative Free Cash Flow of $56 million.

Business Highlights

McKesson signed an agreement in principle to extend its pharmaceutical distribution partnership with CVS Health through June 2027.
McKesson continues to expand its differentiated oncology and biopharma businesses, further demonstrating meaningful progress against its company priorities.
On October 31, 2022, McKesson and HCA Healthcare completed its transaction and formed a joint venture combining McKesson’s US Oncology Research and HCA Healthcare’s Sarah Cannon Research Institute to advance cancer care and increase access to oncology clinical research. McKesson also acquired Genospace, a leading innovator in precision medicine and clinical trial matching.
On November 1, 2022, McKesson closed the transaction of Rx Savings Solutions (RxSS), a prescription price transparency and benefit insight company that offers affordability and adherence solutions to health plans and employers.
McKesson progressed in its planned exit of business operations within the European region and has completed divestitures in 11 of the 12 countries. After entering into an agreement in July 2021 to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group, McKesson closed the transaction on October 31, 2022.
U.S. Pharmaceutical Segment

Second-quarter revenues were $60.1 billion, an increase of 12%, driven by increased volume of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $896 million. Adjusted Segment Operating Profit was $756 million, an increase of 3%, driven by growth in distribution of specialty products to providers and health systems, partially offset by lower demand of COVID-19 vaccine distribution. Excluding the impact of COVID-19 vaccine distribution, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 5%.
Prescription Technology Solutions Segment

Second-quarter revenues were $1.0 billion, an increase of 9%, driven by growth in prescription volumes in our third-party logistics business and higher technology service revenues.
Second-quarter Segment Operating Profit was $120 million. Adjusted Segment Operating Profit was $141 million, a decrease of 2%, driven by higher operating expenses, resulting from increased headcount associated with annual support of customer programs.
Medical-Surgical Solutions Segment

Second-quarter revenues were $2.8 billion, a decrease of 9%, driven by lower sales of COVID-19 tests, partially offset by growth in the primary care business.
Second-quarter Segment Operating Profit was $299 million. Adjusted Segment Operating Profit was $307 million, a decrease of 4%, driven by lower sales of COVID-19 tests, partially offset by organic business performance. Excluding the impact of COVID-19 related items, the Medical-Surgical Solutions segment delivered Adjusted Segment Operating Profit growth of 7%.
International Segment

Second-quarter revenues were $6.2 billion. On an FX-Adjusted basis, revenues were $6.9 billion, a decrease of 25%, driven by the divestitures of McKesson’s UK and Austrian businesses.
Second-quarter Segment Operating Loss was $37 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $151 million, a decrease of 7%, driven by the divestitures of McKesson’s UK and Austrian businesses.
Company Updates

Kathleen Wilson-Thompson, a member of McKesson’s independent Directors, was recognized with the Distinguished Alumna Award by the DirectWomen Organization for her leadership and contributions to board service.
Brian Tyler signed the Disability:IN’s "CEO Letter on Disability Inclusion," reaffirming McKesson’s commitment to create an inclusive workplace for its employees.
Fiscal 2023 Outlook

McKesson raised fiscal 2023 Adjusted Earnings per Diluted Share guidance to $24.45 to $24.95 from the previous range of $23.95 to $24.65 to reflect operating business performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs and COVID-19 tests.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance includes approximately $1.45 to $1.65 of impacts attributable to the following:

Fiscal 2023 Adjusted Earnings per Diluted Share guidance indicates 11% to 14% forecasted growth compared to prior year, excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

McKesson has scheduled a conference call for today, Tuesday, November 1st at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

Upcoming Investor Events

McKesson management will be participating in the following investor conference:

J.P. Morgan Healthcare Conference, January 9-12, 2023
Audio webcast, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.