Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 6) * ADiTx Therapeutics Inc (NASDAQ: ADTX) (announced introduction of AditxtScore for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) * Biocept Inc (NASDAQ: BIOC) (announced an agreement with Aegea for a highly sensitive PCR-based assay designed by the latter for detecting the COVID-19 virus) * DarioHealth Corp (NASDAQ: DRIO) * Denali Therapeutics Inc (NASDAQ: DNLI)( announced selection of candidate to enter Phase 3 study in Parkinson's disease) * Editas Medicine Inc (NASDAQ: EDIT)(moved on M&A speculation) * Emergent Biosolutions Inc (NYSE: EBS) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * Harvard Bioscience, Inc. (NASDAQ: HBIO) * ITAMAR MED LTD/S ADR (NASDAQ: ITMR) * Meridian Bioscience, Inc. (NASDAQ: VIVO) * Natera Inc (NASDAQ: NTRA) * PDL BioPharma Inc (NASDAQ: PDLI) * Sangamo Therapeutics Inc (NASDAQ: SGMO) (reacted to its second-quarter results) * Shockwave Medical Inc (NASDAQ: SWAV) * SurModics, Inc. (NASDAQ: SRDX)(reacted to its second-quarter results) * Twist Bioscience Corp (NASDAQ: TWST) * Unity Biotechnology Inc (NASDAQ: UBX) * Zoetis Inc (NYSE: ZTS) (reacted to its second-quarter results)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Aug. 6) * Nkarta Inc (NASDAQ: NKTX) * Orchard Therapeutics PLC - ADR (NASDAQ: ORTX)(announced its second-quarter results)Stocks In Focus Zosano Clinches Distribution Deal For Investigational Migraine Patch Zosano Pharma Corp (NASDAQ: ZSAN) said it has partnered with Eversana commercialize and distribute Qtrypta in the U.S. Qtrypta is Zosano's transdermal microneedle product candidate for the acute treatment of migraine. In March, the FDA accepted a NDA for Qtrypta and granted a PDUFA goal date of October 20. If approved, Qtrypta would be the first and only microneedle patch indicated for the acute treatment of migraine, Zosano said.The stock jumped 31.62% to $1.79 in after-hours trading.FDA Approves ViiV's Two-Drug Combo Treatment ViiV Healthcare, majority owned by GlaxoSmithKline plc (NYSE: GSK) and Pfizer Inc. (NYSE: PFE), said the FDA approved Dovato - dolutegravir/lamivudine - as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.Novavax Strikes Coronavirus Vaccine Agreements With Takeda, India's Serum Institute Novavax, Inc. (NASDAQ: NVAX) and Takeda Pharmaceutical Co Ltd (NYSE: TAK) announced a partnership for the development of the former's COVID 19 vaccine candidate - NVX CoV2373 - in Japan.Takeda is to receive funding from the Government of Japan's Ministry of Health, Labour and Welfare to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.Separately, Novavax announced a license agreement with Serum Institute of India Private Limited for the development and commercialization of NVX CoV237 in low- and middle-income countries and India. The companies hope to make available a minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries.Novavax shares were adding 2.21% to $171.20, while Takeda was gaining 1.81% to $18.52.Co-Diagnostics' COVID-19 Tests Authorized In Australia Co-Diagnostics Inc (NASDAQ: CODX) said the Logix Smart COVID-19 for use in detecting SARS-CoV-2, the virus that causes COVID-19, has been authorized for use in Australian.The stock was gaining 3.25% to $27 in premarket trading.Roche's Tencentriq-chemo Combo Flunks Breast Cancer Study Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the Phase 3 IMpassion131 study, evaluating Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival for first-line treatment of people with metastatic triple-negative breast cancer, in the PD-L1-positive population.CytoDyn To Request Pre-submission Meetings for Approval of Leronlimab For AIDS and COVID-19 In U.K. CytoDyn Inc (OTC: CYDY) said it will submit requests for pre-submission meetings in the U.K. for leronlimab as a HIV treatment in combination with HAART for highly treatment experienced HIV patients, as well as for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate symptoms.Earnings PDL Biopharma said its second-quarter revenues fell from $7.5 million in 2019 to $5.2 million in 2020. The loss per share widened from 43 cents to 4 cents, while analysts estimated a profit of 10 cents per share.The stock plunged 13.84% to $3.02 in after-hours trading.Adamas Pharmaceuticals Inc's (NASDAQ: ADMS) second-quarter revenues climbed from $12.69 million in 2019 to $18.79 million in 2020, with Gocovri contributing $18 million, up 41% year-over-year. The net loss per share narrowed from 90 cents to 37 cents. Analysts had estimated a wider loss of 61 cents per share.The stock jumped 18.77% to $3.10 in after-hours trading.Coherus Biosciences Inc (NASDAQ: CHRS) reported an increase in its second-quarter revenues from $83.43 million to $135.67 million, and earnings per share improved from 32 cents to 70 cents, while analysts expected earnings of 33 cents per share.In after-hours trading, the stock advanced 13.10% to $19.69.Illumina, Inc.'s (NASDAQ: ILMN) second-quarter revenues fell 25% year-over-year to $633 million, and non-GAAP earnings per share fell from $1.99 to 32 cents.View more earnings on IBBThe stock slid 12.10% to $351 in after-hours trading.GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) reported a year-over-year increase in second-quarter revenues from $72 million in 2019 to $121.3 million in 2020, with Epidiolex revenues at $117.7 million. The company reversed from a profit of 21 cents per share to a loss of 2 cents per share.The stock slipped 9.16% to $120 in after-hours trading.Applied DNA Sciences Inc's (NASDAQ: APDN) fiscal-year third-quarter revenues fell 79% year-over-year to $432,000, with the steep drop reflecting a decrease in licensing revenue in the cannabis industry as well as cannabis feasibility pilots. The loss per share narrowed from $1.55 to 72 cents, but was wider than the consensus loss estimate of 67 cents per share.The stock was retreating 15.68% to $9.25 in premarket trading Friday.Capricor Therapeutics Inc (NASDAQ: CAPR) reported a loss of 23 cents per share for its second quarter compared to a loss of 59 cents in the year-ago period. Analysts, on average, estimated a loss of 37 cents per share for the quarter."We are now well underway in animal studies and have seen promising results showing the mRNA vaccine is capable of generating an antibody response to multiple antigens expressed by COVID-19," the company said.The stock was declining 11.39% to $7 in premarket trading Friday.Vaxart Inc (NASDAQ: VXRT) reported second-quarter revenues of $532,000 in 2020 compared to $85,000 a year-ago. The loss per share narrowed from 39 cents to 12 cents, while analysts estimated a loss of 6 cents per share.Updating on the its coronavirus vaccine program, the company said it is now laser focused on preparing to enter a Phase 1 clinical trial with its lead COVID-19 vaccine candidate, which is an oral tablet.In premarket trading, the stock was adding 11.82% to $10.17.On The Radar PDUFA Dates Trevena Inc (NASDAQ: TRVN) has a tryst with the FDA, with respect to its NDA for its pain drug oleceridine, which was once rejected by the agency on the premise of inadequacy of clinical data.Earnings Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open) Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open) Ocular Therapeutix Inc (NASDAQ: OCUL) (before the market open) Mersana Therapeutics Inc (NASDAQ: MRSN) (before the market open) Jounce Therapeutics Inc (NASDAQ: JNCE) (before the market open) Replimune Group Inc (NASDAQ: REPL) (before the market open)Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates IPOsFreeline Therapeutics Holdings plc, a clinical-stage AAV-based gene therapy company focusing on inherited systemic debilitating diseases, priced its initial public offering, or IPO, of 8.824 million ADSs, representing 8.824 million ordinary shares, at $18 per share compared to the estimated price range of $16-$18, for generating gross proceeds of about $158.8 million. The shares will be listed on the Nasdaq under the ticker symbol FRLN. The offering is expected to close on Aug. 11.Checkmate Pharmaceuticals, Inc., a clinical stage oncology-focused biotech, said it priced its IPO of 5 million shares at $15, at the midpoint of the estimated price range of $14-$16. The company expects to raise gross proceeds of $75 million from the offering. The shares will be listed on the Nasdaq under the ticker symbol CMPI.See more from Benzinga * Moderna Analyst Breaks Down Biopharma's Coronavirus Vaccine Pricing * The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Bristol-Myers Squibb Earnings, Acutus Medical IPO * JPMorgan Turns Bullish On Novavax After Phase 1 Coronavirus Vaccine Readout(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
\- Total revenue increased 68 percent to $121.3 million - \- Epidiolex approved in the U.S. for seizures associated with TSC, launch expected this month - \- Conference call today at 4:30 p.m. EDT –LONDON and CARLSBAD, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced financial results and operating progress for the second quarter ended June 30, 2020.“We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond,” stated Justin Gover, GW’s CEO. “We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year.”FINANCIAL RESULTS * Total revenue for the quarter ended June 30, 2020 was $121.3 million compared to $72.0 million for the quarter ended June 30, 2019 * Net loss for the quarter ended June 30, 2020 was $8.8 million compared to net income of $79.7 million for the quarter ended June 30, 2019. The prior year quarter included net proceeds of $104.1 million from the sale of a Rare Pediatric Priority Review Voucher. * Cash and cash equivalents at June 30, 2020 were $477.6 millionOPERATIONAL HIGHLIGHTS * Epidiolex (cannabidiol) progress: * Total Q2 net product sales of Epidiolex of $117.7 million * U.S. commercial update * U.S. Epidiolex Q2 net product sales of $111.1 million * TSC indication approved by FDA, August commercial launch planned * TSC payer reimbursement anticipated quickly following launch * European commercial update * Ex-U.S. Epidyolex Q2 net product sales of $6.6 million * Pricing & reimbursement progress in Germany, France and Italy * TSC EMA submission under review * Clinical progress with additional indications * Phase 3 trial in Rett Syndrome expected to re-commence in H2 2020 * Strengthening commercial exclusivity * Orphan exclusivity in both the U.S. and EU * 3 new patents granted and listed in Orange Book, bringing total of 13 patents listed in Orange Book, 12 of which expire in 2035 * One recent patent listed is a non-use patent directed to the oral formulation * Epidiolex composition patent application in process * TSC patent applications under review * Nabiximols * MS Spasticity Clinical program * Three positive Phase 3 MS spasticity trials already completed outside of the U.S. * Five new MS Spasticity Phase 3 trials expected to commence in H2 2020 (2) and H1 2021 (3), any one of which could enable a NDA submission * Phase 3 muscle tone studies – placebo-controlled cross-over design * N=52; Expected start: Q4 2020 * N=190; Expected start: Q1 2021 * N=36 (nabiximols responders); Expected start: Q1 2021 * Phase 3 spasm frequency studies – placebo-controlled parallel group * N=450; Expected start: Q4 2020 * N=~200 (nabiximols responders); Expected start: Q2 2021 * Spinal Cord Injury (SCI) spasticity clinical program * Three SCI trials expected to be initiated in 2020 and 2021 * N=~100 (observational clinical discovery study); Expected start: Q4 2020 * N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021 * N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021 * Post-Traumatic Stress Disorder (PTSD) clinical program * Phase 2/3 study in PTSD (N=~ 325); Expected start: H1 2021 * Additional pipeline programs * Schizophrenia (GWP42003) * Phase 2b trial expected to commence H2 2020 * CBDV in autism trials expected to recommence in H2 2020 * 30-patient open label study in autism * Investigator-led 100 patient placebo-controlled trial in autism * 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 EMAConference Call and Webcast InformationGW Pharmaceuticals will host a conference call and webcast today at 4:30 pm EDT. To participate in the conference call, please dial 833-937-1050 (toll free from the U.S. and Canada) or 845-403-8302 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. 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: 35770.About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. GW is currently carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.Forward-looking statements This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.Enquiries:GW Pharmaceuticals plc Stephen Schultz, VP Investor Relations917 280 2424 / 401 500 6570 U.S. Media Enquiries: Sam Brown Inc. Healthcare Communications Christy Curran Mike Beyer615 414 8668 312 961 2502 Ex-U.S. media enquiries Ben Atwell, FTI Consulting+44 (0)203 727 1000 GW PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) (unaudited) June 30, December 31, 2020 2019 Assets Cash and cash equivalents $477,557 $536,933 Accounts receivable, net 80,357 48,883 Inventory 99,620 85,528 Prepaid expenses and other current assets 30,183 28,292 Total current assets 687,717 699,636 Property, plant, and equipment, net 125,106 127,765 Operating lease assets 22,333 24,916 Intangible assets 5,627 — Goodwill 6,959 6,959 Deferred tax assets 18,123 18,123 Other assets 4,715 4,850 Total assets $870,580 $882,249 Liabilities and stockholders’ equity Accounts payable $16,238 $9,990 Accrued liabilities 93,313 99,374 Current tax liabilities 2,004 437 Other current liabilities 6,947 7,760 Total current liabilities 118,502 117,561 Long-term liabilities: Finance lease liabilities 5,066 5,573 Operating lease liabilities 19,659 21,650 Other liabilities 10,416 11,431 Total long-term liabilities 35,141 38,654 Total liabilities 153,643 156,215 Commitments and contingencies Stockholders’ equity: Common stock - Ordinary shares par value £0.001; 373,709,720 shares outstanding as of June 30, 2020; 371,068,436 shares outstanding as of December 31, 2019 575 570 Additional paid-in capital 1,655,500 1,632,046 Accumulated deficit (854,752) (837,959) Accumulated other comprehensive loss (84,386) (68,623) Total stockholders’ equity 716,937 726,034 Total liabilities and stockholders’ equity $870,580 $882,249 GW PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Revenues Product net sales $121,230 $71,489 $241,762 $110,463 Other revenue 67 549 168 822 Total revenues 121,297 72,038 241,930 111,285 Operating expenses Cost of product sales 8,708 6,620 19,477 11,751 Research and development 45,734 32,467 91,608 62,842 Selling, general and administrative 75,894 62,273 147,077 117,351 Total operating expenses 130,336 101,360 258,162 191,944 Loss from operations (9,039) (29,322) (16,232) (80,659) Interest income 250 2,310 1,519 4,397 Interest expense (297) (268) (581) (533) Other income - 104,117 - 104,117 Foreign exchange gain 1,386 2,026 1,366 912 (Loss) income before income taxes (7,700) 78,863 (13,928) 28,234 Income tax expense (benefit) 1,128 (885) 2,865 (1,450) Net (loss) income $(8,828) $79,748 $(16,793) $29,684 Net loss per share: Basic $(0.02) $0.21 $(0.04) $0.08 Diluted $(0.02) $0.21 $(0.04) $0.08 Weighted average shares outstanding: Basic 375,525 371,712 374,680 370,776 Diluted 375,525 377,435 374,680 376,674 GW PHARMACEUTICALS PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited) Six Months Ended June 30, 2020 2019 Cash flows from operating activities Net loss $(16,793) $29,684 Adjustments to reconcile net loss to net cash used in operating activities: Foreign exchange (gain) loss (488) 882 Share-based compensation 24,677 23,330 Depreciation and amortization 5,514 4,808 Gain from sale of priority review voucher — (104,117) Other 27 21 Changes in operating assets and liabilities: Accounts receivable, net (31,794) (27,924) Inventory (19,669) (27,070) Prepaid expenses and other current assets (4,312) (6,819) Other assets 1,884 1,542 Accounts payable 6,625 3,488 Current tax liabilities 2,732 619 Accrued liabilities (599) 13,887 Other liabilities (2,145) (2,192) Net cash used in operating activities (34,341) (89,861) Cash flows from investing activities Proceeds from sale of priority review voucher — 104,117 Additions to property, plant and equipment (11,362) (22,515) Additions to capitalized software (1,455) (1,017) Additions to intangible assets (6,404) — Net cash (used) provided by in investing activities (19,221) 80,585 Cash flows from financing activities Proceeds from exercise of stock options 5 2,878 Payments in connection with common stock withheld for employee tax obligation (1,223) — Payments on finance leases (146) (250) Payments on landlord financing obligation (283) (273) Net cash (used in) provided by financing activities (1,647) 2,355 Effect of exchange rate changes on cash (4,167) (893) Net decrease in cash and cash equivalents (59,376) (7,814) Cash and cash equivalents at beginning of period 536,933 591,497 Cash and cash equivalents at end of period $477,557 $583,683 Supplemental disclosure of cash flow information: Income taxes paid 251 3,907 Interest paid 581 533 Supplemental disclosure of noncash information: Property and equipment purchases in accounts payable and accrued liabilities 1,727 856 Right-of-use asset obtained in exchange for operating liabilities 275 —