Acorda Reports Third Quarter 2020 Financial Results

On November 3, 2020 Acorda Therapeutics, Inc. (NASDAQ:ACOR) reported its financial results for the third quarter ended September 30, 2020 (Press release, Acorda Therapeutics, NOV 3, 2020, View Source [SID1234569765]).

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"We are encouraged by the 24% increase in INBRIJA net sales over the second quarter, even with the challenges posed by the second wave of COVID-19. We are also pleased that coverage for INBRIJA continued to increase during the quarter, with over 96% of commercially-insured patients now having access to it," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In addition, AMPYRA’s performance and the milestone payment we received for FAMPYRA have further strengthened our financial position. We are also continuing our work to reduce operating costs and monetize excess capacity at our Chelsea facility, to help drive long-term value for all shareholders."

Third Quarter 2020 Financial Results
For the quarter ended September 30, 2020, the Company reported INBRIJA net revenue of $5.8 million, compared to $4.9 million for the same quarter in 2019.

For the quarter ended September 30, 2020, the Company reported AMPYRA net revenue of $27.3 million compared to $39.3 million for the same quarter in 2019. As previously announced, AMPYRA lost its exclusivity in September 2018.

Research and development (R&D) expenses for the quarter ended September 30, 2020 were $5.7 million, including $0.6 million of share-based compensation compared to $16.1 million, including $0.7 million of share-based compensation for the same quarter in 2019.

Sales, general, and administrative (SG&A) expenses for the quarter ended September 30, 2020 were $39.9 million, including $1.8 million in share-based compensation compared to $48.7 million, including $2.4 million in share-based compensation for the same quarter in 2019.

The Company received a $15 million milestone payment from Biogen International GmbH under its license and collaboration agreement with Biogen, based on Biogen’s ex-U.S. net sales of FAMPYRA exceeding $100 million over the four consecutive quarters ending with the third quarter of 2020. The Company will retain approximately $14 million of the milestone payment net of the Company’s payment obligations to another party.

Change in fair value of derivative liability for the quarter ended September 30, 2020 was $4.9 million.

Provision for income taxes for the quarter ended September 30, 2020 was $1.5 million compared to a provision for income taxes of $0.02 million for the same quarter in 2019.

The Company reported GAAP net income of $7.3 million for the quarter ended September 30, 2020, or $.05 per diluted share. GAAP net loss in the same quarter of 2019 was $263.5 million, or $5.55 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2020 was $10.9 million, or $0.23 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $21.9 million, or $0.46 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 the derivative liability and asset impairment charges. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $101 million compared to $253 million at September 30, 2019. Restricted cash includes $37 million in escrow related to the 6% semi-annual interest portion of the convertible note exchange completed in December 2019. If the Company is permitted under the terms of the notes and elects to pay interest due in stock, the restricted cash will be released from escrow.

For full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 – $110 million, and operating expenses to be $170 – $180 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast and Conference Call
The Company will host a conference call today at 4:30 p.m. ET. To participate in the Webcast/Conference call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
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To register for the Conference Call, use the link below:
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**When registering please type your phone number with no special characters**.
A replay of the call will be available from 8:30 p.m. ET on November 3, 2020 until 11:59 p.m. ET on December 3, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4177747. 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 loss, adjusted to exclude the items below, and has provided 2020 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net loss, when viewed in conjunction with our 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 outstanding 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 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) asset impairment charges that are not routine to the operation of the business, (v) changes in the fair value of the derivative liability which is a non-cash charge and not related to the operation of the business, and (vi) expenses that pertain to a non-routine restructuring event. The Company believes its non-GAAP net loss measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net loss, we have provided 2020 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward-looking nature of this information, the amount of compensation charges needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to a non-routine restructuring, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

Quest Diagnostics To Speak At The Credit Suisse 29th Annual Virtual Healthcare Conference

On November 3, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Credit Suisse 29th Annual Virtual Healthcare Conference (Press release, Quest Diagnostics, NOV 3, 2020, View Source [SID1234569764]). Steve Rusckowski, Chairman, President & CEO will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, and the company’s current perspective on the impact of the COVID-19 pandemic. The presentation is scheduled for Tuesday, November 10, 2020 at 11:45 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 48 hours after the conclusion of the live event and will remain available until December 10, 2020.

GW Pharmaceuticals plc Reports Third Quarter 2020 Financial Results and Operational Progress

On November 3, 2020 GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported financial results and operating progress for the third quarter ended September 30, 2020 (Press release, GW Pharmaceuticals, NOV 3, 2020, View Source [SID1234569763]).

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"We are pleased to report strong revenue growth in the 3rd quarter despite the challenges presented by COVID-19. Epidiolex meets a serious unmet need within the field of epilepsy and we expect the product to demonstrate continued strong growth in the months and years ahead. The recent expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers," stated Justin Gover, GW’s Chief Executive Officer. "We have also now commenced the pivotal Phase 3 program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission, including as early as next year. Beyond nabiximols, we are advancing several clinical-stage pipeline candidates, including the recent start of a Phase 2 trial in schizophrenia."

FINANCIAL RESULTS

Total revenue for the quarter ended September 30, 2020 was $137.1 million compared to $91.0 million for the quarter ended September 30, 2019
Total revenue for the first nine months of 2020 of $378.6 million compared to $202.3 million in the prior year period
Net loss for the quarter ended September 30, 2020 was $12.2 million compared to net loss of $13.8 million for the quarter ended September 30, 2019
Cash and cash equivalents at September 30, 2020 were $480.3 million
OPERATIONAL HIGHLIGHTS

Epidiolex (cannabidiol) progress:
Total Q3 net product sales of Epidiolex of $132.6 million
U.S. commercial update
U.S. Epidiolex Q3 net product sales of $121.6 million
TSC indication launched with high prescriber awareness and near universal payer coverage
Expanded payer coverage
85 million lives with no/broad prior authorization (+47% year-to-date)
Ex-U.S. commercial update
Ex-U.S. Epidyolex Q3 net product sales of $11.0 million
UK pricing and reimbursement in place. Progress in Germany, France, Italy and Spain
TSC EMA submission under review
Epidyolex approved in Australia
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
13 patents listed in Orange Book, 12 of which expire in 2035
Patents include formulation and method of use
Epidiolex composition patent application in process
Two further Orange Book listable patents to be allowed or granted by Q1 2021
Nabiximols development program:
First Phase 3 MS Spasticity trial underway
Phase 3 placebo-controlled spasm frequency study (N=450)
MS Spasticity trials due to commence
Phase 3 placebo-controlled muscle tone studies:
N=52; Expected start Q4 2020 (subject to COVID)
N=190; Expected start: Q1 2021
N=36 (nabiximols responders); Expected start: Q1 2021
Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
N=~100 (observational clinical discovery study); Expected start: Q1 2021
N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021
Additional pipeline programs:
Schizophrenia (GWP42003)
Phase 2b trial now actively recruiting
Autism:
CBD formulation Phase 2 study expected to commence in Q1 2021
CBDV investigator-led 100 patient placebo-controlled trial in autism – recruitment now resumed
New botanical cannabinoid pipeline product (GW541)
Phase 1 trial underway
Potential targets within field of neuropsychiatry
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1b safety study in patients continues to recruit
Orphan Drug and Fast Track Designations granted from FDA and EMA
Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast today at 8:30 am EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at View Source A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 38272.

Oncodesign announces Drug Discovery Cooperation with ViraTherapeutics, a Boehringer Ingelheim subsidiary

On November 3, 2020 ONCODESIGN (ALONC – FR0011766229) (Paris:ALONC), a biopharmaceutical group specialized in precision medicine, reported the signature of a new multi-year service agreement (DDSA1) with ViraTherapeutics, a subsidiary of Boehringer Ingelheim based in Innsbruck (Austria) and specialized in oncolytic viral immunotherapy (Press release, Oncodesign, NOV 3, 2020, View Source [SID1234569762]).

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Under this agreement, Oncodesign will play a key role for Austrian biotech company ViraTherapeutics, handling the preclinical assessment of its immunotherapy programs, which aim to develop next-generation vesicular stomatitis virus (VSV-GP) variants in immuno-oncology.

This two-year partnership deal falls within Oncodesign’s development strategy of supporting pharmaceutical and biotech companies during the early development stages of their therapeutic innovations under global strategic alliances.

"We are delighted that we will be working together under this agreement with ViraTherapeutics, a leading innovator in the development of oncolytic viral therapies and part of Boehringer Ingelheim. We are thrilled to be playing our part in their various ground-breaking oncology programs", commented Fabrice Viviani, Managing Director and Head of the Oncodesign Services Business Unit.

"We are proud that ViraTherapeutics chose us as a key partner for conducting its oncolytic virus assessments. This partnership once again confirms the relevance and interest of the industry for our DDSA service offering. It is a tremendous encouragement to consolidate our efforts to put in place strategic agreements with innovative biotech companies and leading decision-makers in the pharmaceutical industry, in order to bring new therapeutic solutions to market as fast as possible to improve patient treatments and meet the strong therapeutic demand in oncology and infectious diseases", added Philippe Genne, Chairman, Chief Executive Officer and Founder of Oncodesign.

HOOKIPA Pharma To Report Third Quarter 2020 Financial Results on November 12, 2020

On November 3, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it will release financial results for the third quarter ended September 30, 2020 before the market opens on Thursday, November 12, 2020 (Press release, Hookipa Pharma, NOV 3, 2020, View Source [SID1234569754]).

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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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The Company will not be conducting a conference call in conjunction with this earnings release. Until otherwise noted, the Company will only conduct an earnings conference call in conjunction with its fourth quarter earnings releases.