On August 3, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2022 and provides a business update (Press release, INmune Bio, AUG 3, 2022, View Source [SID1234617515]).

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Q2 2022 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro and INB03):

Dosed the first patient in the Phase II trial using XPro (XPro1595) to treat patients with mild Alzheimer’s Disease (AD) in April. The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Multiple secondary endpoints of cognition will also be measured, including CDR-SB, ADAS-COG13 and other endpoints. Data is anticipated in the second half of 2023.
FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing. The Company is addressing the FDA’s manufacturing procedure query to alleviate the current hold and start the US trials sites for XPro1595 in AD as a soon as possible. While trials in the United States are on hold, INmune continues to enroll and open additional treatment sites in Australia.
INmune completed the manufacture of new doses of XPro during the quarter, enough to supply all Phase 2 programs and continue the expansion of our pre-clinical research in new disease targets for XPro therapy.
The Company presented data demonstrating XPro promotes remyelination in white matter in rodent models of Multiple Sclerosis at European Conference on Neuroinflammation.
INB03 – presented data at the AACR (Free AACR Whitepaper) Conference and HER2+ Targeted Therapy Summit showing INB03’s ability to reverse Mucin 4 (MUC4) expression, a negative predictor of treatment success, in HER2 breast cancer cell line (JIMIT-1) to re-establish sensitivity to trastuzumab and tyrosine kinase inhibitors.
Patent issued for use of XPro for central nervous systems diseases: "METHODS OF TREATING NEUROLOGICAL DISEASES," a patent directed to use of Dominant Negative Tumor Necrosis Factor variants, such as the Company’s XPro, by peripheral administration for crossing the blood-brain barrier and treating diseases of the Central Nervous System. This patent provides protection for XPro treatment in CNS diseases to 2033 with possible patent term extension of up to five additional years if requested by the Company and approved by the USPTO under 35 U.S.C. 156.
INKmune Platform:

The Company continues to monitor the high-risk myelodysplastic syndrome (MDS) cancer patient and the two compassionate use acute myeloid leukemia (AML) patients who have been treated with INKmune in a Phase 1 open label dose escalation trial.
Two weeks ago, a young patient with refractory AML after failed BMT was treated with INKmune. She received three doses of INKmune without side effects. We will be monitoring her progress closely. She is another patient with a high level of disease burden.
Received national registration for the INKmune MDS trial in the UK which allows for patients from any hospital to be enrolled in the trial at Southampton University Hospital. Additionally, the Company will be expanding its INKmune MDS trial into the EU with a new site in Athens, Greece.
Expanded ongoing INKmune treatment in MDS Phase 1 trial to include patients with AML. The Company has recently treated a new patient with AML on a compassionate basis who failed the inclusion criteria for AML patients in the trial.
Upcoming Milestones:

Initiate Xpro Phase 2 program for AD02 (mild AD) and AD03 (mild cognitive impairment) in US patients once clinical hold is lifted.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, once clinical hold is lifted.
Initiate INKmune Phase I program in a solid tumor in 1H 2023.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML by 1H 2023.
Report top-line data from Phase 2 trial of Xpro in AD03 patients in 2H 2023.
Report top-line data from Phase 2 trial of XPro in AD02 patients in late 2023 or early 2024.
Report pre-clinical INKmune data in at least two new solid tumor indications, renal cell carcinoma and nasopharyngeal carcinoma.
"In April, we announced the dosing of our first patient treated with XPro1595 in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in Phase II clinical trial, AD02," stated RJ Tesi, M.D., CEO of INmune Bio. "The trial is a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States. Although the trial in the United States is currently on hold pending conclusion of the FDA’s manufacturing inquiry, we continue to enroll patients in Australia where the trial is proceeding as planned. Additionally, our plan to launch additional blinded, randomized, placebo-controlled Phase II trials in patients with mild cognitive impairment (MCI) and TRD will occur after the clinical hold is lifted.

"Our INKmune platform continues to make positive strides. We are actively expanding the INKmune program towards the treatment of solid tumors. INKmune primed NK cells have unique biologic characteristics that should make the therapy effective in solid tumors," concluded Dr. Tesi.

Financial Results for the Quarter Ended June 30, 2022:

Net loss attributable to common stockholders for the quarter ended June 30, 2022 was approximately $6.8 million, compared to approximately $6.7 million for the quarter ended June 30, 2021.

Research and development expense totaled approximately $4.2 million for the recent quarter compared to approximately $4.5 million during the quarter ended June 30, 2021.

General and administrative expense was approximately $2.2 million for the quarter compared to approximately $2.1 million during the quarter ended June 30, 2021.

Other expense was approximately $0.5 million for the quarter ended June 30, 2022 compared to approximately $ 0.1 million during the quarter ended June 30, 2021.

As of June 30, 2022, the Company had cash and cash equivalents of approximately $61.2 million.

As of August 3, 2022, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: August 3, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728540

A live audio webcast of the call can be accessed using this link: View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 10, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728540.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

On August 3, 2022 McKesson Corporation (NYSE:MCK) reported results for the first-quarter ended June 30, 2022 (Press release, McKesson, AUG 3, 2022, View Source [SID1234617444]).

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"McKesson had a solid start to fiscal 2023. Our results this quarter demonstrate the strength of our streamlined portfolio and successful execution as a diversified healthcare services company," said Brian Tyler, chief executive officer. "Our talented associates continue to deliver exceptional performance, and we remain confident that our strategy positions McKesson for long-term growth and value creation. As a result of our first-quarter operating performance and the continuation of COVID-19 response efforts, we are raising our guidance for fiscal 2023 Adjusted Earnings per Diluted Share to $23.95 to $24.65."

First-quarter revenues were $67.2 billion, an increase of 7% from a year ago, 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 planned progress with McKesson’s divestiture of its European businesses.

First-quarter earnings per diluted share from continuing operations was $5.25 compared to $3.09 a year ago, an increase of $2.16.

First-quarter Adjusted Earnings per Diluted Share was $5.83 compared to $5.56 a year ago, an increase of 5%, driven by growth across the North American businesses and a lower share count, partially offset by a higher tax rate and lower contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government. First-quarter Adjusted Earnings per Diluted Share also included pre-tax net losses of approximately $22 million associated with McKesson Ventures’ equity investments, compared to pre-tax net gains of approximately $7 million in the first-quarter of fiscal 2022.

For the first three months of the fiscal year, McKesson returned $1.1 billion of cash to shareholders, which included $1.0 billion of common stock repurchases and $71 million of dividend payments. During the first three months of the fiscal year, McKesson used cash from operations of $941 million, and invested $100 million in capital expenditures, resulting in negative Free Cash Flow of $1.0 billion.

Capital Deployment Updates

McKesson maintains a disciplined approach to capital allocation, centered on delivering sustainable growth and long-term shareholder value. McKesson’s capital allocation framework consists of three pillars:

Prioritizing growth by investing internally and making acquisitions that support our strategic priorities.
Returning capital to shareholders through share repurchases and McKesson’s commitment to a growing dividend. Share repurchases are principally used to return cash to shareholders in absence of growth investment opportunities.
Maintaining a strong balance sheet, including strong Free Cash Flow generation, which provides ample liquidity and financial flexibility.
On July 22, 2022, McKesson’s Board of Directors declared a 15% increase to its quarterly dividend from $0.47 per share to $0.54 per share.

On July 22, 2022, McKesson’s Board of Directors authorized the company to repurchase up to an additional $4.0 billion of its common shares in a manner deemed in the best interest of the company and its stockholders, considering other growth opportunities and prevailing business and market conditions. Fiscal 2023 Adjusted Earnings per Diluted Share guidance continues to assume approximately $3.5 billion of share repurchases.

Business Highlights

Oncology: On June 23, 2022, McKesson announced an agreement to form a joint venture combining McKesson’s U.S. Oncology Research and HCA Healthcare’s Sarah Cannon Research Institute. Together, the joint venture will create a fully integrated oncology research organization aimed at expanding clinical research, accelerating drug development, and increasing availability and access to clinical trials for community oncology providers and patients, including those in underserved communities. The transaction is anticipated to close in 2022.
Europe: McKesson progressed in its planned exit of business operations within the European region and has completed divestitures or entered into agreements to sell 11 of the 12 countries.
After entering into an agreement in June 2022 to sell its Denmark business to Erhvervsinvest, McKesson closed the transaction on July 29, 2022.
After entering into an agreement in November 2021 to sell its UK business to AURELIUS, McKesson closed the transaction on April 6, 2022.
In July 2021, McKesson announced an agreement to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group. The transaction is expected to close in the second half of fiscal 2023.
Norway remains the only country that McKesson has not entered into an agreement to sell.
COVID-19: McKesson continues to play a leading role in the fight against COVID-19. McKesson renewed its partnership with the U.S. government to support the COVID-19 response efforts. The vaccine distribution contract has been extended through July 2023; and the kitting, storage, and distribution of ancillary supplies contract has been extended through January 2023.
U.S. Pharmaceutical Segment

First-quarter revenues were $56.9 billion, an increase of 14%, resulting from increased specialty product volumes, including retail national account customers, and market growth, partially offset by branded to generic conversions.
First-quarter Segment Operating Profit was $696 million. Adjusted Segment Operating Profit was $711 million, an increase of 4%, 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 9%.
Prescription Technology Solutions Segment

First-quarter revenues were $1.1 billion, an increase of 21%, driven by our biopharma services programs due to prescription volume growth, and third-party logistics and technology service revenues.
First-quarter Segment Operating Profit was $144 million. Adjusted Segment Operating Profit was $165 million, an increase of 19%, driven by growth from access, affordability, and adherence solutions.
Medical-Surgical Solutions Segment

First-quarter revenues were $2.6 billion, an increase of 3%, driven by growth in the primary care business, partially offset by lower sales of COVID-19 tests and lower contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
First-quarter Segment Operating Profit was $256 million. Adjusted Segment Operating Profit was $268 million, an increase of 4%, driven by organic business performance as well as growth and improvements in the primary care business.
International Segment

First-quarter revenues were $6.5 billion. On an FX-Adjusted basis, revenues were $7.1 billion, a decrease of 23%, driven by the divestitures of McKesson’s UK and Austrian businesses.
First-quarter Segment Operating Loss was $6 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $152 million, a decrease of 11%, driven by the divestitures of McKesson’s Austrian and UK businesses, partially offset by the reduction of depreciation and amortization on European assets under agreements to sell.
Opioid-Related Litigation

McKesson has settled, or reached agreements to settle, the opioid-related claims of all 50 states, as well as the District of Columbia and all eligible territories.
On May 3, 2022, McKesson reached an agreement in principle with the State of Washington.
On June 27, 2022, McKesson reached an agreement in principle with the State of Oklahoma.
On July 4, 2022, after a full trial, a federal judge ruled that McKesson along with two other distributors could not be held liable to two West Virginia subdivisions for contributing to the opioid crisis.
Corporate Responsibility Updates

McKesson was recognized by Forbes as one of the "Best Employers for Women," achieving an industry-leading ranking and demonstrating its outstanding progress in promoting gender equity and diversity in the workplace.
For the seventh consecutive year, McKesson was named a "Best Place to Work for Disability Inclusion." McKesson earned a top-ranking score of 100 on the 2022 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disability:IN.
Fiscal 2023 Outlook

McKesson raised fiscal 2023 Adjusted Earnings per Diluted Share guidance to $23.95 to $24.65 from the previous range of $22.90 to $23.60 to reflect first-quarter operating 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 $0.99 to $1.29 of impacts attributable to the following:

Fiscal 2023 Adjusted Earnings per Diluted Share guidance, excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results, indicates 10% to 15% forecasted growth compared to prior year.

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

Conference Call Details

McKesson has scheduled a conference call for today, Wednesday, August 3rd 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:

Morgan Stanley Healthcare Conference, September 13, 2022
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 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.

On August 3, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2022, affirmed 2022 financial guidance1 and provided business updates (Press release, Jazz Pharmaceuticals, AUG 3, 2022, View Source [SID1234617443]).

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"We’ve had a highly productive second quarter across commercial, R&D and corporate development that has resulted in meaningful progress towards Vision 2025. We have also achieved an important milestone and for the first time there are now more patients taking Xywav than Xyrem," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Execution remains our primary focus as we aim to maximize the value of Xywav in idiopathic hypersomnia (IH) and narcolepsy, grow Epidiolex in the U.S. and expand the launch of Epidyolex globally, build on the successful launch of Rylaze and progress the development program for Zepzelca. We are also advancing a number of mid- and late-stage programs in our pipeline with multiple Investigational New Drug (IND) applications expected through 2023, and are pleased our pan-RAF inhibitor, JZP815, was cleared by the FDA to enter clinical development."

"We have achieved our net leverage2 ratio target ahead of our stated timeline and therefore our focus will be to continue to manage the balance sheet through disciplined capital allocation, providing us with further flexibility to pursue corporate development opportunities," said Renée Galá, executive vice president and chief financial officer of Jazz Pharmaceuticals. "Our strong second quarter financial results and top- and bottom-line growth put us well on track to achieve our 2022 financial guidance. Operational excellence will also remain a key area of focus for us as we build the foundation for future growth and progress toward achieving Vision 2025."

Key Highlights

Business and Execution

Continued robust launch momentum of Xywav for IH.
Achieved a significant milestone in 2Q22, with more active oxybate patients taking Xywav than Xyrem.
Completed Marketing Authorization Application (MAA) submission for JZP458 (approved as Rylaze in the U.S.) to European Medicines Agency (EMA) in May 2022, with potential for approval in 2023.
Announced the U.S. Food and Drug Administration (FDA) cleared the IND application that will allow JZP815 to enter clinical development.
Strengthened leadership in sleep medicine with addition of a potent, highly selective oral orexin-2 receptor agonist, JZP441 (DSP-0187).
Expanded oncology pipeline with JZP898 (WTX-613), a differentiated, conditionally activated IFNα INDUKINE molecule.
Strategically divested Sunosi, allowing for increased investment and sharpened focus on highest strategic priorities.
Financial

Growing and durable commercial franchises drove 2Q22 total revenues of $932.9 million; 24% increase compared to the same period in 2021.
2022 total revenue guidance affirmed at $3.5 to $3.7 billion.
Achieved net leverage ratio target six months ahead of our stated timeline. Net leverage ratio of 3.2×2 as of June 30, 2022, demonstrates rapid deleveraging following the close of the GW Pharmaceuticals (GW) acquisition.
_______________________

1. The Company has updated its GAAP guidance primarily to reflect the impact of foreign currency exchange movements on non-USD denominated amortization and inventory step up expense. The Company is affirming its non-GAAP adjusted guidance.

2. On a pro forma non-GAAP adjusted basis. Non-GAAP net leverage ratio is a non-GAAP financial measure. For further information, see "Non-GAAP Financial Measures."

Business Updates

Key Commercial Products

Oxybate (Xywav and Xyrem):

Net product sales for the combined oxybate business increased 10% to $504.4 million in 2Q22 compared to the same period in 2021.
Average active oxybate patients on therapy was approximately 17,100 in 2Q22, an increase of approximately 8% compared to the same period in 2021.
The Company achieved a significant milestone in 2Q22, with more active oxybate patients taking Xywav than Xyrem.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

Xywav net product sales increased 89% to $235.0 million in 2Q22 compared to the same period in 2021.
There were approximately 8,700 active Xywav patients exiting 2Q22.
Xywav has broad patent protection to 2033.
Xywav for Narcolepsy:

There were approximately 7,550 narcolepsy patients taking Xywav exiting 2Q22.
The benefits of lowering sodium intake continue to resonate with patients and prescribers. In June 2021, FDA recognized seven years of Orphan Drug Exclusivity (ODE), through July 2027, for Xywav and published its summary of clinical superiority findings stating that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem." Further, FDA stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated."
Xywav for Idiopathic Hypersomnia (IH):

Continued robust launch momentum with approximately 1,150 IH patients taking Xywav exiting 2Q22.
The Company has achieved its goal of obtaining similar payer coverage to narcolepsy with coverage now at approximately 90% of commercial lives for IH.
The Company launched Xywav for IH in November 2021, with initial launch efforts focused on the approximately 37,000 currently diagnosed patients in the U.S. who are actively seeking healthcare. Healthcare providers are excited to have a treatment option with positive and compelling clinical trial results that addresses IH and not just its symptoms.
FDA recognized ODE for IH in January 2022, extending regulatory exclusivity to August 2028.
Xyrem (sodium oxybate) oral solution:

Xyrem net product sales decreased 19% to $269.4 million in 2Q22 compared to the same period in 2021, reflecting the continued adoption of Xywav by patients with narcolepsy.
Epidiolex/Epidyolex (cannabidiol):

Epidiolex/Epidyolex net product sales increased 12% to $175.3 million in 2Q22 compared to the same period in 2021, on a proforma basis.
Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, Germany, Italy and Spain, with an anticipated launch in France this year. The Company anticipates a total of 10 new market and indication launches across 2022, continuing to drive growth of Epidyolex ex-U.S.
The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, shortly.
The Company expects to initiate a pivotal Phase 3 trial for Epidiolex in Japan for Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Dravet Syndrome (DS) this year.
Zepzelca (lurbinectedin):

Zepzelca net product sales increased 22% to $68.3 million in 2Q22 compared to the same period in 2021.
The Company is pleased to have established Zepzelca as the treatment of choice in the second-line small cell lung cancer (SCLC) setting after only eighteen months on the market.
Zepzelca development program highlights:
In March 2022, the first patient was enrolled in the EMERGE-201 Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors.
In November 2021, Jazz and collaborator F. Hoffmann-La Roche Ltd (Roche) initiated a Phase 3 trial to evaluate first-line use of Zepzelca in combination with Tecentriq (atezolizumab), compared to Tecentriq alone, as maintenance therapy in patients with extensive-stage SCLC after induction chemotherapy.
The Company’s partner, PharmaMar, initiated a confirmatory trial, LAGOON, in second-line SCLC in December 2021. If positive, this trial could confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):

Rylaze net product sales were $73.0 million in 2Q22.
The continued strong launch of Rylaze reflects the significant unmet patient need for a high-quality, reliable supply of Erwinia asparaginase for patients with acute lymphoblastic leukemia.
In May 2022, the Company completed the MAA submission to EMA for a M/W/F dosing schedule and IM and IV administration for JZP458 (approved as Rylaze in the U.S.) with potential for approval in 2023. The Company is also advancing the program for potential submission, approval and launch in Japan.
In January 2022, the Company completed the submission of a supplemental Biologics Licensing Application (sBLA) to FDA seeking approval for a M/W/F IM dosing schedule for Rylaze. In April 2022, the Company completed the submission of an sBLA to FDA seeking approval for IV administration of Rylaze. Both submissions are being reviewed under the Real-time Oncology Review Program (RTOR).
Corporate Development

JZP441 (DSP-0187) Agreement:

On May 4, 2022, the Company and Sumitomo Pharma Co., Ltd. (Sumitomo) announced an exclusive license agreement for JZP441, a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling.
JZP898 (WTX-613) Agreement:

On April 7, 2022, the Company and Werewolf Therapeutics (Werewolf) announced a licensing agreement under which the Company acquired exclusive global development and commercialization rights to Werewolf’s investigational molecule, WTX-613, now called JZP898, a differentiated, conditionally activated IFNα INDUKINE molecule.
Sunosi (solriamfetol) Strategic Divestiture:

On May 9, 2022, the Company completed the U.S. divestiture of Sunosi to Axsome Therapeutics (Axsome).
The Company and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition.
Key Pipeline Highlights

Nabiximols:

On June 28, 2022, the Company announced the Phase 3 RELEASE MSS1 trial (NCT04657666) did not meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).
The Company continues to assess the RELEASE MSS1 trial results, which will be presented at a future medical meeting.
Suvecaltamide (JZP385):

Suvecaltamide, a highly selective modulator of T-type calcium channels, is in clinical development for the treatment of essential tremor.
Patient enrollment is ongoing and top-line data read-out is anticipated in 1H24.
JZP150:

JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder (PTSD).
Patient enrollment is ongoing and top-line data read-out is anticipated in late 2023.
The Company received Fast Track Designation for JZP150 development in PTSD from FDA in 4Q21, underscoring the significant unmet medical needs of patients.
JZP815:

In 2Q22, the Company announced that FDA cleared the IND application, which will allow JZP815 to enter clinical development.
The pan-RAF inhibitor program is part of a novel class of next-generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors.
The Company, together with its preclinical collaboration partner, Redx Pharma, presented its first preclinical data in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022.
JZP815 inhibited tumor growth in several RAS- and BRAF-mutated solid tumor models, and demonstrated enhanced activity when combined with other MAPK pathway inhibitors.
Financial Highlights

1. Adjusted EPS for the three and six months ended June 30, 2022 was impacted by $0.51 per share and $0.95 per share, respectively, following the adoption of ASU 2020-06.

2. The Company adopted ASU No. 2020-06, "Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity", (ASU 2020-06) on January 1, 2022. Following adoption, diluted EPS must be calculated using the if-converted method which assumes full conversion of our Exchangeable Senior Notes.

GAAP net income (loss) in 2Q22 was $34.7 million, or $0.55 per diluted share, compared to $(363.3) million, or $(6.11) per diluted share, for 2Q21. Non-GAAP adjusted net income in 2Q22 was $305.5 million, or $4.30 per diluted share, compared to $240.6 million, or $3.90 per diluted share, for 2Q21. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

1. Net product sales for Epidiolex/Epidyolex and Sativex are included from the acquisition of GW on May 5, 2021.

2. Net product sales for Sunosi U.S. are included until the date of divestment to Axsome of May 9, 2022.

Total revenues increased 24% in 2Q22 compared to the same period in 2021.

Neuroscience net product sales in 2Q22 increased 20% to $696.8 million compared to the same period in 2021 primarily driven by Epidiolex/Epidyolex net product sales of $175.3 million, following the acquisition of GW. In 2Q22, oxybate net product sales increased 10% to $504.4 million.
Oncology net product sales in 2Q22 increased 40% to $229.8 million compared to the same period in 2021 primarily driven by Rylaze net product sales in 2Q22 of $73.0 million following product launch in July 2021, partially offset by Erwinaze/Erwinase net product sales in 2Q21 of $28.3 million.
Operating Expenses and Effective Tax Rate

1. The fluctuations in the GAAP effective tax rates for the three and six months ended June 30, 2022 and 2021 are as a result of changes in the mix of pre-tax income and losses across our jurisdictions and the impact of the change in the statutory tax rate in the U.K. on the 2021 periods.

Operating expenses increased in 2Q22 over the prior year period primarily due to the following:

Cost of product sales increased in 2Q22 compared to the same period in 2021, on a GAAP and on a non-GAAP adjusted basis, due to increased net product sales. In addition, GAAP cost of product sales was impacted by a higher acquisition accounting inventory fair value step-up expense in 2Q22.
Selling, general and administrative (SG&A) expenses decreased in 2Q22 compared to the same period in 2021, on a GAAP basis, primarily due to lower GW acquisition related transaction and integration expenses, offset by the loss on disposal of Sunosi. SG&A expenses, on a GAAP and non-GAAP adjusted basis, included increased compensation-related expenses driven by the inclusion of GW related headcount costs for the full quarter offset by lower Sunosi U.S. marketing costs in 2Q22.
Research and development (R&D) expenses increased in 2Q22 compared to the same period in 2021, on a GAAP and on a non-GAAP adjusted basis, primarily due to the inclusion of a full quarter of GW employee costs and clinical program spend for Epidiolex and nabiximols in 2Q22, offset by a reduction in costs related to JZP458 (Rylaze) and JZP385.
Acquired in-process research and development (IPR&D) expense in 2Q22 on a GAAP and on a non-GAAP adjusted basis primarily related to upfront payments of $50.0 million and $15.0 million to Sumitomo and Werewolf, respectively, in connection with our licensing agreements.
Cash Flow and Balance Sheet

As of June 30, 2022, cash, cash equivalents and investments were $771.3 million, and the outstanding principal balance of the Company’s long-term debt was $6.1 billion compared to $6.4 billion as of December 31, 2021. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million. For the six months ended June 30, 2022, the Company generated $512.0 million of cash from operations. In 1Q22 the Company repaid in full the $251.0 million remaining aggregate principal amount of the Euro Term Loan B.

2022 Financial Guidance

The Company has updated its GAAP guidance primarily to reflect the impact of foreign currency exchange movements on non-USD denominated amortization and inventory step up expense. The Company is affirming its non-GAAP adjusted guidance.

1. Excludes $270-$300 million of amortization of acquisition-related inventory fair value step-up, $13-$15 million of share-based compensation expense and $2 million of transaction and integration related expenses relating to the acquisition of GW from estimated GAAP gross margin.

2. Excludes $148-$168 million of share-based compensation expense, $31-$41 million of transaction and integration related expenses relating to the acquisition of GW and $40-$50 million of costs related to the disposal of Sunosi from estimated GAAP SG&A expenses.

3. Excludes $59-$67 million of share-based compensation expense and $2 million of transaction and integration related expenses relating to the acquisition of GW from estimated GAAP R&D expenses.

4. Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income.

5. Non-GAAP adjusted EPS guidance for 2022 reflects dilution of $2.05, at the midpoint, post adoption of ASU 2020-06. Diluted EPS calculations for 2022 include 9 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to net income of $29 million on a GAAP basis, when dilutive, and $25 million on a non-GAAP basis, under the "if converted" method.

6. See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2022 Net Income Guidance" at the end of this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2022 second quarter results.

Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the call to ensure adequate time for any software downloads that may be necessary.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

On August 3, 2022 CivicaScriptTM, a public benefit company dedicated to bringing lower-cost generic medicines to U.S. consumers, reported the availability of its first product: abiraterone acetate 250 mg tablets (Press release, CivicaScript, AUG 3, 2022, View Source [SID1234617432]). Abiraterone is used together with steroid medication (prednisone) to treat prostate cancer that has spread to other parts of the body.

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Starting today, CivicaScript will offer abiraterone 250 mg for sale to pharmacies for $160 per bottle of 120 tablets – typically a month’s supply. CivicaScript recommends that pharmacies charge patients no more than $171 per bottle (CivicaScript’s maximum retail price, or MaxRP).

This is about $3,000 per month less than the average cost2 for someone with Medicare Part D, the type of insurance people with prostate cancer are most likely to have. Part D patients who use CivicaScript’s abiraterone product will significantly reduce their out-of-pocket cost both during the deductible phase, in which they pay full price for drugs, and during the "doughnut hole" phase, when they again face substantial out-of-pocket costs.

Abiraterone was chosen by CivicaScript members as a priority generic medicine based on its high list price from other manufacturers and significant patient need for the product.

"This is a proud day for CivicaScript as we advance our mission to make generic medicines affordable and available to everyone," said CivicaScript President Gina Guinasso. "I want to thank our members for their active participation in our drug-selection process, which ensures we are focusing on the right medications at the right time, and where we believe we can have immediate impact on people’s lives."

CivicaScript was co-founded in 2020 by Civica Inc., the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies to bring affordable versions of common but high-priced generic medicines to market. Its model is to identify select high-priced generic medicines and work with manufacturing partners to bring them to market at a fraction of their current cost. CivicaScript then works with like-minded payors, PBMs and pharmacies across the country who pass along the cost savings to their customers.

While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be due to lack of competition in the market. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. CivicaScript, its members and its manufacturing partners are intent on addressing that problem.

"We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market," said Kim Keck, president and CEO of BCBSA. "This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication."

Initially, CivicaScript’s abiraterone will be available through Lumicera Health Services, a specialty pharmacy that focuses on medicines for chronic and serious conditions, and through Intermountain Healthcare. Additional pharmacies will be listed on the CivicaScript website as they come on board. "We welcome the partnership of other health plans, employers and pharmacies who share our belief that patients come before profits," Guinasso said.

The guiding principle for CivicaScript’s portfolio development is to target both specialty and traditional generics where there is greatest opportunity to substantially reduce prices for patients. The organization is initially focused on six to 10 medications for which there currently is not enough market competition to ensure low, sustainable prices.

Starting in 2024, CivicaScript also intends to distribute low-priced insulin, which will be manufactured by Civica, subject to FDA approval. Civica is building a state-of-the-art manufacturing facility in Petersburg, Virginia, and has entered into a co-development and commercial agreement with GeneSys Biologics for three insulin biosimilars: glargine, lispro and aspart (biologics corresponding to Lantus, Humalog and Novolog, respectively).

Civica plans to set a recommended price to the consumer of no more than $30 per insulin vial and no more than $55 for a box of five insulin pen cartridges, a significant discount to prices charged to uninsured individuals today.3

On August 3, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, for the treatment of acute myeloid leukemia (AML) (Press release, Sumitomo Pharmaceuticals, AUG 3, 2022, View Source [SID1234617431]).

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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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"We are pleased to have received this designation for DSP-5336 which reinforces the need to identify novel therapeutic options to improve outcomes for patients with AML," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "We are excited to contribute to the advancement of research in this hematologic malignancy."

The FDA’s Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. AML is a blood cancer that starts in bone marrow. Bone marrow typically produces white blood cells, red blood cells and platelets. However, in people with AML, the bone marrow makes abnormal cancerous white blood cells called myeloid blasts. AML swiftly moves from the bone marrow into your bloodstream and can even involve other parts of your body.1

"MLL gene rearrangements and nucleophosmin 1 (NPM1) mutations are potent drivers of leukemia growth, and menin is a necessary copilot. DSP-5336 is a small molecule that blocks the MLL-menin partnership which inhibits normal differentiation and promotes leukemia growth."2-5 detailed Jatin J. Shah, M.D., Chief Medical Officer of Sumitomo Pharma Oncology, Inc. "We’re encouraged by preclinical evidence showing that blocking the menin-MLL interaction may stop the development of leukemia and restore normal terminal differentiation in MLL rearranged and NPM1-mutant malignant myeloid cells."2,6

DSP-5336 is currently being evaluated in a Phase 1/2 clinical trial to evaluate the safety and efficacy of DSP-5336 in patients with Relapsed/Refractory AML/ ALL with or without MLL Rearrangement or NPM1 Mutation, which is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment, visit clinicaltrials.gov (NCT04988555).

This is the third recently announced Orphan Drug Designation from SMP Oncology. TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, was granted Orphan Drug Designation for the treatment of myelofibrosis (NCT04176198) as well as DSP-0390, an investigational emopamil-binding protein (EBP) inhibitor, was also granted Orphan Drug Designation for the treatment of brain cancer (NCT05023551). These designations support the strength and diversity of SMP Oncology’s pipeline and commitment to oncology research and development.

About DSP-5336
DSP-5336 is an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2,3 In preclinical studies DSP-5336 has shown selective growth inhibition in human acute leukemia cell lines with MLL rearrangements or NPM1 mutations.2,6 DSP-5336 is currently being evaluated in a Phase 1/2 dose escalation/dose expansion study of DSP-5336 in patients with relapsed or refractory AML (NCT04988555).