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 [SID1234622758]).

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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."

Webcast and Conference Call
The Company will host a webcast in conjunction with its third quarter update and financial results today at 4:30 p.m. ET.

To participate in the Webcast, please use the following registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on November 1, 2022 until 11:59 p.m. ET on December 1, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 945092. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income (loss), adjusted to exclude the items below, and has provided 2022-2027 adjusted operating expense and adjusted EBITDA guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net income (loss), when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (v) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. The Company believes its non-GAAP net income (loss) measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding the Company’s projected operating performance. In addition, management uses this non-GAAP financial measure to establish budgets and operational goals, to manage the Company’s business, and to evaluate its performance.

In addition to non-GAAP net income (loss), we have provided non-GAAP projections of adjusted OPEX and adjusted EBITDA. Adjusted OPEX includes (i) research and development expenses and (ii) selling, general, and administrative expenses and excludes (i) costs of goods sold, (ii) amortization of intangible assets, (iii) change in fair value of derivative liability, and (iv) change in fair value of acquired contingent liability. Adjusted EBITDA is GAAP net income (loss) before income taxes excluding (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) interest due on our convertible debt, (iii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iv) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (v) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (vi) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. We are unable to reconcile these forward-looking non-GAAP measures to GAAP due to the forward-looking nature of the adjustments that are needed to determine this information, which includes information regarding future compensation charges, future changes in the market price of our common stock, and changes in the fair value of derivative and contingent liabilities, none of which are available at this time.

Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP, and the calculation of the non-GAAP financial measures included herein may differ from similarly titled measures used by other companies. The Company believes that the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock, and (iii) other items as set forth above that are not ascertainable at the present time. We believe these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding expected operating performance. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and evaluate its performance.

On November 1, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported third quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, NOV 1, 2022, View Source [SID1234622757]).

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"Physician adoption, patient satisfaction, and payer access drove continued strong ARCALYST performance in the third quarter. We remain focused on positioning ARCALYST as the standard of care for recurrent pericarditis, with the goal of broadening our reach and helping even more patients," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Additionally, with the profitable ARCALYST collaboration and initial proceeds from the global license agreement with Genentech for the rights to develop and commercialize vixarelimab, we are well-positioned to execute on synergistic growth opportunities across our portfolio, including the expansion of our ARCALYST cardiovascular franchise."

Corporate Update

·In September 2022, Kiniksa announced the closing of its global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab in exchange for $100 million in upfront and near-term payments, approximately $600 million in clinical, regulatory, and sales-based milestones before fulfilling upstream obligations, and royalties on annual net sales.

Portfolio Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

·ARCALYST net revenue was $33.4 million for the third quarter of 2022.
-Greater than 650 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch.Greater than 90% payer approval rate of completed patient cases for recurrent pericarditis in the third quarter of 2022.
·As of the end of the third quarter of 2022, the average duration of initial therapy in the commercial setting was approximately 12 months, and approximately 35% of recurrent pericarditis patients who had discontinued ARCALYST therapy restarted treatment.

KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

·Kiniksa is enrolling the second and final cohort of the multiple ascending dose portion of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. Following completion of this portion of the trial, the proof-of-concept portion will begin. The company expects data from the trial in the first half of 2024.

Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

·Kiniksa is pursuing collaborative study agreements to evaluate the potential of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated.

Upcoming Scientific Conference Presentation

·Kiniksa reported that an abstract highlighting long-term extension (LTE) data from RHAPSODY, the pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, has been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2022.1,2
·LTE data included in the abstract demonstrated rilonacept treatment beyond 18 months resulted in continued treatment response.
-The median [maximum at end of LTE] duration of continuous rilonacept therapy for all patients in RHAPSODY was 18 [27] months for US patients (n=45) and 27 [33] months for non-US patients (n=29).3
-The annualized incidence of pericarditis recurrences while on therapy for all patients (n=74) during the first 18 months of the LTE portion of the trial was 0.04 events per patient-year.
-Patients were given the option at 18 months from their most recent pericarditis recurrence to continue or suspend rilonacept treatment for observation.

1 Dr. Massimo Imazio of University Hospital Santa Maria della Misericordia, Udine, will present a poster presentation entitled Prolonged Rilonacept Treatment in RHAPSODY Long-Term Extension Provided Persistent Reduction of Pericarditis Recurrence Risk on Sunday, November 6, 2022, from 3:45 to 4:45 p.m. Central Time (4:45 – 5:45 p.m. Eastern Time).

2 Data in the abstract are as of the abstract cutoff date; final data are under embargo until the poster presentation.

3 Upon commercial availability of ARCALYST for recurrent pericarditis in April 2021, the LTE portion in the US ended, and patients continuing therapy transitioned to commercial ARCALYST. Non-US patients remained in the LTE without interruption until the LTE closed in June 2022.

§75% of patients who suspended treatment (n=8) experienced pericarditis recurrence (n=6). The median [interquartile range (IQR)] time-to-event was 11.8 [3.7, Not-Estimable (NE)] weeks.
§There was a 98.2% reduction in risk of recurrent pericarditis events in patients who continued rilonacept treatment beyond 18 months (Hazard Ratio = 0.018, p<0.0001).

Financial Results

·Total revenue for the third quarter of 2022 was $99.1 million, compared to $12.1 million for the third quarter of 2021.
-Total revenue for the third quarter of 2022 included $33.4 million in ARCALYST net product revenue and $65.7 million in license and collaboration revenue from the vixarelimab global license agreement with Genentech. Kiniksa did not report license and collaboration revenue in the third quarter of 2021.
·Total operating expenses for the third quarter of 2022 were $52.7 million, compared to $42.8 million for the third quarter of 2021.
-Total operating expenses for the third quarter of 2022 included $4.6 million in collaboration expense. Kiniksa did not report collaboration expense in the third quarter of 2021.
-Total operating expenses for the third quarter of 2022 included $6.0 million of non-cash, share-based compensation expense, compared to $6.2 million for third quarter of 2021.
·Net income for the third quarter of 2022 was $224.1 million, compared to a net loss of $30.5 million for the third quarter of 2021.
-Net income for the third quarter of 2022 included a $177.4 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets.
·As of September 30, 2022, the company had $200.7 million of cash, cash equivalents, and short-term investments and no debt.

Financial Guidance

·Kiniksa continues to expect ARCALYST net revenue for the full-year 2022 of between $115 million and $130 million.
·Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2025.

Conference Call Information

·Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, November 1, 2022, to discuss third quarter 2022 financial results and to provide a corporate update.
·Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On November 1, 2022 Veeva Systems (NYSE: VEEV) reported a ten-year strategic partnership agreement with Merck (NYSE: MRK), known as MSD outside of the United States and Canada, that builds on the existing 12-year partnership between the companies (Press release, Merck & Co, NOV 1, 2022, View Source [SID1234622752]). Under the terms of the agreement, Merck will take a Veeva-first approach to new industry-specific software and data, selecting Veeva products when they are fit for purpose to maximize the value of Veeva’s integrated, cloud-based platform and products. Veeva will provide Merck with a strategic pricing approach and Merck will have input into Veeva’s product roadmap. The partnership helps accelerate Merck’s digital strategy and makes it more efficient for Merck to evaluate, purchase, operate, and create value from Veeva products and services.

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"Transforming our digital, data, and analytics capabilities is integral to enabling our global colleagues to deliver on our purpose of using the power of leading-edge science to save and improve lives around the world," said Robert M. Davis, chief executive officer and president, Merck. "Our strategic partnership with Veeva expands our capacity to leverage innovative technology and enhances our ability to deliver value to patients and all our stakeholders – this is key to how we measure success."

"I am excited to see our partnership with Merck evolve to this strategic level," said Veeva CEO Peter Gassner. "Our teams share a common passion for the industry and an understanding of strategic partnership. I look forward to seeing what we create together over the coming years."

Additional Information Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems Follow @veeva_eu on Twitter: twitter.com/veeva_eu

On November 1, 2022 Dragonfly Therapeutics, Inc. ("Dragonfly"), reported that the first patient has been dosed in a clinical trial being conducted by Merck, known as MSD outside the United States and Canada, to evaluate a solid tumor targeting TriNKET developed by Dragonfly (Press release, Dragonfly Therapeutics, NOV 1, 2022, https://www.prnewswire.com/news-releases/dragonfly-therapeutics-announces-first-patient-dosed-in-clinical-trial-evaluating-solid-tumor-targeting-trinket-conducted-by-merck-301663741.html [SID1234622751]). Dragonfly will receive an undisclosed milestone payment triggered by this event.

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"Across both our 1.0 and 2.0 collaborations, Merck has been an extraordinary partner in oncology, immune disorders and other fields," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are delighted that the first immunotherapy candidate from our initial collaboration has advanced into the clinic, and equally enthusiastic by the progress we are making together on bringing Dragonfly’s TriNKET technology to targets that address other indications."

The companies’ collaboration, initially focused on a number of solid tumor targets, began in October 2018. The collaboration was subsequently expanded in 2020 with a multi-target agreement to develop and commercialize additional natural killer ("NK") cell engager immunotherapies in oncology, infectious disease and immune disorders. Merck licensed this first TriNKET immunotherapy candidate from Dragonfly in November 2020.