Ligand Pursuing Plans for OmniAb to Become a Standalone Public Company

On November 9, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it is pursuing plans to split Ligand into two separate, publicly traded companies with one featuring the OmniAb business, and the other featuring Ligand’s existing collection of core royalties and the technologies, pipeline and contracts associated with the Pelican protein expression platform and the Captisol business (Press release, Ligand, NOV 9, 2021, View Source [SID1234595035]). The spin-off is intended to create two companies with dedicated operational focus, business-specific capital allocation, agility to meet partner needs, and compelling focused investment profiles.

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"Our OmniAb business continues to have an outstanding year with the first regulatory approval for an OmniAb-derived antibody received during the third quarter and a second approval anticipated by year-end," said John Higgins, CEO of Ligand. "We believe more than ever that OmniAb offers one of the industry’s leading antibody discovery platforms and that the business is primed for success for years to come. After significant planning and analysis, we have concluded we are operating two distinct, high-growth companies within Ligand. Along with outside advisors we have determined the time is right to pursue a strategic plan to create two independent companies and accelerate investment into the OmniAb platform and technologies to further drive value."

Based on initial management and advisor review, an IPO and eventual distribution of OmniAb shares to Ligand shareholders is the leading option under consideration at this time. The IPO would be of newly issued shares of OmniAb, Inc., which would include the Ab Initio computational antigen design technology, Icagen’s ion channel technology, the xPloration high-throughput screening technology, and the suite of OmniAb transgenic animals used for antibody discovery. In an IPO, Ligand expects OmniAb to issue less than 20% of its common stock, with Ligand retaining the remaining interest, which would eventually be distributed to Ligand stockholders in a manner generally intended to qualify as a tax-free transaction. Ligand’s OmniAb strategic review is in response to the ongoing success of OmniAb, as well as the opportunity to unlock the value of this business. Ligand’s Board of Directors has not approved a specific course of action, and Ligand will continue to evaluate other options to optimize value and ensure flexibility to invest in growth. There can be no assurance that this process will result in Ligand pursuing a particular transaction or consummating any such transaction.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The latest corporate presentation can be accessed at investor.ligand.com.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss third quarter financial results as well as this announcement, and to answer questions. To participate via telephone, please dial (833) 540-1167 from the U.S. or (929) 517-0358 from outside the U.S., using the conference ID 5486177. To participate via live or replay webcast, a link is available at www.ligand.com.

About OmniAb

The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities to further leverage across modalities, including antibody-drug conjugates and others. The OmniAb suite of technologies and differentiating computational capabilities and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.

Acorda Therapeutics Announces Agreement to Commercialize INBRIJA® in Germany

On November 9, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has entered into distribution and supply agreements with Esteve Pharmaceuticals GmbH (ESTEVE) to commercialize INBRIJA 33 mg (levodopa inhalation powder, hard capsules) in Germany (Press release, Acorda Therapeutics, NOV 9, 2021, View Source [SID1234595034]). INBRIJA is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. (1) Acorda had previously announced an agreement with ESTEVE to commercialize INBRIJA in Spain.

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"We are delighted to announce this second commercialization agreement with ESTEVE, which will make INBRIJA available to the many people with Parkinson’s in Germany who would benefit from an "as needed" treatment for their OFF periods," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "ESTEVE has an impressive track record of successfully commercializing pharmaceuticals in Europe for neurological and other indications. We continue to be in active discussions with additional companies for the rights to distribute INBRIJA in other countries in Europe and the rest of the world."

Under the terms of the distribution agreement, ACORDA will receive a €5 million upfront payment, and will receive additional sales-based milestones. ACORDA will also receive a significant double-digit percent of the selling price of INBRIJA in Germany in exchange for supply of the product. ESTEVE will have the exclusive distribution rights to INBRIJA in Germany and ACORDA will supply the product to ESTEVE. ESTEVE expects to launch INBRIJA in Germany by mid-2022.

According to current population estimates, there are up to 400,000 people living with Parkinson’s disease in Germany, and there are 20 new cases per 10,000 people per year. (2)

ALX Oncology Announces Updated Data from Ongoing Clinical Trial (ASPEN-01) of Evorpacept Showing Emerging Clinical Benefit in Survival-Based Endpoints in Patients with Advanced Solid Tumors

On November 9, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported updated results from ASPEN-01, an ongoing evorpacept phase 1b study, evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s ("SITC") 36th Anniversary Annual Meeting [abstract 498] (Press release, ALX Oncology, NOV 9, 2021, View Source [SID1234594998]).

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ALX Oncology reports updated results from both cohorts: the gastric/gastroesophageal junction cancer ("GC") patient cohort receiving evorpacept plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma ("HNSCC") patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy. All data reflect response evaluable patients as of September 1, 2021. The SITC (Free SITC Whitepaper) 36th Anniversary Annual Meeting poster is available to download under "Publications" in the Science section of the ALX Oncology website at www.alxoncology.com.

In patients with >2L HER2 positive GC (n=18), evorpacept in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial objective response rate ("ORR") of 72.2% with a median duration of response ("mDOR") of 14.8 months, a 12-month overall survival ("OS") rate of 79%, and a median overall survival ("mOS") of 17.1 months. These results compare favorably with the clinical experience of both ramucirumab + paclitaxel and trastuzumab-deruxtecan in similar populations.

In patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=13), evorpacept demonstrates an initial ORR of 38.5% with a 12-month OS rate of 87.5% and mOS not reached in combination with pembrolizumab + 5FU + platinum. These results compare favorably with benchmark survival data from standard pembrolizumab + chemotherapy in the 1L HNSCC setting where ORR is a less reliable predictor for clinical benefit compared to longer-term metrics such as 12-month OS rate and mOS (the gold standard of clinical benefit) in patients with aggressive disease.
In patients with ≥2L HNSCC who have not received a prior checkpoint inhibitor ("CPI") (n=10), long-term follow-up data shows that evorpacept + pembrolizumab demonstrates a 12-month OS rate of 80% with a mOS of 24.5 months, which compares favorably with standard pembrolizumab therapy in patients with 2L CPI naïve HNSCC.

Preliminary data suggest that evorpacept is well tolerated when combined with the multi-agent chemotherapy regimens studied with no maximum tolerated dose reached.
"These updated data provide growing support that evorpacept in combination with the standard regimens studied may translate into a meaningful survival benefit in patients with advanced HNSCC and GC who historically have poor outcomes," said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea.

"The consistency and predictive value of evorpacept’s emerging survival-based data in aggressive solid tumor diseases is highly encouraging," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are excited to investigate the impact of evorpacept on these longer-term measures of clinical benefit in our randomized phase 2 programs in patients with HNSCC (ASPEN-03 and ASPEN-04) and GC (ASPEN-06)."

Conference Call on November 9th at 8:00 a.m. EST
ALX Oncology will host a conference call on Tuesday, November 9, 2021 at 8:00 a.m. EST to further discuss the recent GC and HNSCC data from ASPEN-01, the Phase 1b study of evorpacept that was presented at the SITC (Free SITC Whitepaper) 36th Anniversary Annual Meeting. In addition to ALX Oncology’s executive management team, Dr. Kevin Harrington, Professor of Biological Cancer Therapies and Head of the Division of Radiotherapy and Imaging at the Institute of Cancer Research, London, UK will be featured on the call to discuss the latest evorpacept clinical data in HNSCC patients.

To access the conference call, please dial (844) 467-7655 (U.S./Canada) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 1291278. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.

Cardinal Health Reports First Quarter Fiscal 2022 Results

On November 9, 2021 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2022 revenues of $44.0 billion, an increase of 13% from the first quarter of last year (Press release, Cardinal Health, NOV 9, 2021, View Source [SID1234594997]). First quarter GAAP operating earnings were $415 million and GAAP diluted earnings per share (EPS) were $0.94. Prior year first quarter GAAP results included an operating loss of $624 million due to a $1.0 billion pretax accrual related to opioid litigation. Non-GAAP operating earnings decreased 15% to $527 million in the quarter, primarily due to a decline in Medical segment profit. Non-GAAP diluted earnings per share decreased 15% to $1.29.

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"Our first quarter results were in line with our expectations," said Mike Kaufmann, CEO of Cardinal Health. "We are reaffirming our full-year non-GAAP EPS guidance, despite our expectation that we will see greater inflationary pressures in the Medical segment for the remainder of the year, which we are taking action to mitigate. With an additional $3 billion share repurchase authorization and our commitment to our dividend, we are positioned to return capital to shareholders, while prioritizing investment in our growth businesses, technology and digital transformation, simplifying our operating model, and strengthening our core businesses," Kaufmann concluded.

First-quarter revenue for the Pharmaceutical segment increased 13% to $39.8 billion, driven primarily by branded pharmaceutical sales growth from large Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit increased 1% to $406 million in the first quarter. This reflects an improvement in volumes compared to the prior year, which was adversely impacted by COVID-19. This improvement was largely offset by investments in technology enhancements.

First-quarter revenue for the Medical segment increased 5% to $4.1 billion, driven primarily by PPE sales. This was partially offset by the divestiture of the Cordis business.

Medical segment profit decreased 46% to $123 million in the first quarter primarily due to elevated supply chain costs. To a lesser extent, this also reflects the divestiture of the Cordis business as well as net favorability in the prior year attributed to COVID-19.

Fiscal year 2022 outlook1
The company reaffirmed its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.60 to $5.90.

This guidance includes an update to Medical segment profit outlook to mid-single to low-double digit percentage decline, from low-double digit percentage growth. This update reflects net incremental elevated supply chain costs of approximately $100 million to $125 million. Additionally, the company updated expectations for its fiscal 2022 non-GAAP effective tax rate to 23% to 25%, from 23.5% to 25.5%, and its diluted weighted average shares outstanding to 280 million to 282 million, from 287 million to 292 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Long-term financial targets
The company announced long-term segment profit targets of low to mid-single digit growth in the Pharmaceutical segment and mid to high-single digit growth in the Medical segment. The company is also targeting to average a double-digit combined Non-GAAP EPS growth and dividend yield.

Recent highlights

Cardinal Health Board of Directors approved a 3-year authorization to repurchase up to an additional $3 billion of Cardinal Health common shares, which will expire on December 31, 2024.
Cardinal Health, along with pharmaceutical distribution peers, announced that enough states have agreed to participate in the previously announced proposed settlement agreement to proceed to the next phase, which is the subdivision sign-on period.
Cardinal Health announced a comprehensive talent strategy to increase representation of diverse employees at the manager level and above by 2030 and established a goal to reduce Scope 1 and Scope 2 greenhouse gas emissions 50% by 2030.
Cardinal Health announced that it has extended its agreements with CVS Health to distribute pharmaceuticals to retail pharmacies and distribution centers through June 30, 2027.
Cardinal Health announced an agreement with TerraPower that will help develop and produce Actinium-225, which will be utilized in drug trials involving targeted alpha therapy for diseases such as breast, prostate, colon and neuroendocrine cancers, melanoma and lymphoma.
Cardinal Health announced its efforts to commercialize and broaden access to over-the-counter rapid COVID-19 tests through partnerships with Abbott and Quidel Corporation.
Upcoming webcasted investor events

Credit Suisse 30th Annual Healthcare Conference at 10:30 a.m. EST, November 10, 2021
J.P. Morgan 40th Annual Healthcare Conference on January 10-13, 2022
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. EST to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until November 8, 2022.

Oncternal Therapeutics to Present at the 12th Annual Jefferies London Healthcare Conference

On November 9, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will present and participate virtually at the 12th Annual Jefferies London Healthcare Conference (Press release, Oncternal Therapeutics, NOV 9, 2021, View Source [SID1234594994]).

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Time and date: Virtual presentation available on-demand beginning on Thursday, November 18 at 8:00 a.m. GMT / 3:00 a.m. ET through Friday, November 19 at 5:00 p.m. GMT / 12:00 p.m. ET
Presenter: James Breitmeyer, M.D., Ph.D., President and CEO
Webcast Link: View Source
Links to the webcast and replay will be accessible on the Events & Presentations page of the Investors section on the Company’s website at investor.oncternal.com.