SB206

Novan Enters into Agreement to Sell Substantially All of its Assets, including Berdazimer Gel, 10.3% (SB206), and Files for Chapter 11 Protection

Retrieved on: 
Monday, July 17, 2023
Communication, Bankruptcy, APA, United States Bankruptcy Court for the Southern District of New York, Dollar for Dollar, DIP, Electric Bond and Share Company v. Securities and Exchange Commission, Sale, Stalking, Title 11 of the United States Code, Associate, Novin, Bankruptcy Code, PDUFA, PAI, Ligand Pharmaceuticals, United States bankruptcy court, SB206, Security (finance), Insolvency and Bankruptcy Code, 2016, FDA, Pharmaceutical industry, Cryptocurrency

DURHAM, N.C., July 17, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (Nasdaq: NOVN) and its wholly owned subsidiary, EPI Health, LLC (collectively, “the Company” or “Novan”), today announced that it has entered into a stalking horse asset purchase agreement (“APA”) with Ligand Pharmaceuticals, Inc. (“Ligand”) (Nasdaq: LGND) prior to filing voluntary petitions for relief under chapter 11 of title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware (the “Chapter 11 Case”). The Company continues to operate its business as a “debtor-in-possession” (“DIP”) under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and orders of the Bankruptcy Court. The Company also entered into a secured DIP credit facility with Ligand in the principal amount of $15.0 million.

Key Points: 
  • The Company also entered into a secured DIP credit facility with Ligand in the principal amount of $15.0 million.
  • The APA governs the sale of substantially all the assets of the Company for $15 million to be paid in cash at closing.
  • Novan has engaged Raymond James & Associates to advise on its strategic options, including the process to sell its assets in connection with the Chapter 11 Case.
  • Additional information about the Chapter 11 Case, including access to Bankruptcy Court documents, is available online at www.kccllc.net/novan .

Novan Focuses Strategic Direction and Announces Restructuring

Retrieved on: 
Wednesday, May 31, 2023
Face, Stock dilution, NDA, Sale, Molluscum contagiosum, Novin, PDUFA, SB206, Bank

DURHAM, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that following an evaluation of its commercial and developmental stage assets, it has decided to sharpen its focus and resources on berdazimer gel, 10.3% (SB206) and announced that it continues to explore strategic alternatives, with a focus on its commercial product portfolio and a sale or out-license of one or more of its commercial products.

Key Points: 
  • Novan conducted a deliberate and thorough review of its commercial and development portfolio of assets to determine a path to optimally deploy capital and maximize shareholder value.
  • Following this review, the Company, has initiated a process to explore a sale or out-license of its commercial assets, including RHOFADE, MINOLIRA, and CLODERM.
  • After careful consideration, we have made the strategic decision to implement a reduction in force of our commercial team and continue to explore a sale or out-license of our commercial assets.
  • The Company took this step to concentrate its resources on pursuing the regulatory approval for the Company’s berdazimer gel, 10.3% product candidate.

Novan Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, May 15, 2023
Ligand Pharmaceuticals, Rosacea, Advertising, EPI, Satō, Drug development, File, Marketing, Novin, NDA, Health, Nitric oxide, Prescription, Consultant, Acquisition, Molluscum contagiosum, PDUFA, Webcast, SB206, Growth, Research, FDA, Conference, Cryptocurrency, Pharmaceutical industry, Video game, Dermatology

DURHAM, N.C., May 15, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its financial and operating results for the first quarter ended March 31, 2023, and provided a corporate update. The Company will host a conference call and webcast, today, May 15, 2023, at 8:30 a.m. ET (details below).

Key Points: 
  • ET –
    DURHAM, N.C., May 15, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its financial and operating results for the first quarter ended March 31, 2023, and provided a corporate update.
  • “Turning to our commercial portfolio, the first quarter of 2023 marked a noteworthy increase in the number of new prescription writers across our promoted products.
  • 9% prescription growth in first quarter 2023 compared to first quarter 2022;
    26% increase in total writers in first quarter 2023 compared to first quarter 2022; and
    1% increase in units sold in first quarter 2023 compared to first quarter 2022.
  • 19% prescription growth in first quarter 2023 compared to first quarter 2022;
    18% increase in new prescriptions compared to first quarter 2022; and
    23% increase in units sold in first quarter 2023 compared to first quarter 2022.

Ligand Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, Telephone, Fulvestrant, GAAP, Congress, Investment, Focal segmental glomerulosclerosis, Patient, NYSE, PROTECT, Novartis, LGG, NASH, Mutation, Element, Forecasting, EMA, Proteinuria, Molluscum contagiosum, PDUFA, Growth, SB206, FDA, Lancet, THC, Total, Safety, Pelican, CDK, Microcystic lymphatic malformation, COVID-19, FSGS, BRAF, Immunoglobulin A, Research, Therapy, NVS, ESR1, NDA, Income tax, Woman, Sale, Trial of the century, Nephrology, Physician, EPS, Breast cancer, Cryptocurrency, Pharmaceutical industry, Travers Smith, Ligand, IgA nephropathy

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three months ended March 31, 2023, and provided an operating forecast and business updates.

Key Points: 
  • Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three months ended March 31, 2023, and provided an operating forecast and business updates.
  • Core Captisol sales were $10.6 million for the first quarter of 2023, compared with $6.2 million for the same period in 2022.
  • Contract revenue was $16.2 million for the first quarter of 2023, compared with $11.0 million for the same period in 2022.
  • Ligand is increasing 2023 revenue and EPS guidance provided on its fourth quarter earnings call held on February 22, 2023.

Novan to Host Analyst and Investor Event: A Discussion of Molluscum’s Unmet Need with Pediatric Dermatologist Jeffrey Sugarman, MD, PhD

Retrieved on: 
Thursday, April 20, 2023
San Francisco, Society, Public health, Dermatitis, Doctor of Philosophy, MD, Molluscum contagiosum, Novin, SB206, Family, Dermatology

DURHAM, N.C., April 20, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that it will host an Analyst and Investor Event: A Discussion of Molluscum’s Unmet Need with Pediatric Dermatologist Jeffrey Sugarman, MD, PhD, on Tuesday, April 25, 2023, at 2:00 PM ET.

Key Points: 
  • DURHAM, N.C., April 20, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that it will host an Analyst and Investor Event: A Discussion of Molluscum’s Unmet Need with Pediatric Dermatologist Jeffrey Sugarman, MD, PhD, on Tuesday, April 25, 2023, at 2:00 PM ET.
  • He is a past-president for the Society for Pediatric Dermatology and is the immediate past president of the California Society of Dermatology.
  • In addition to the moderated discussion, investors and interested parties will have the opportunity to submit questions live during the event.
  • A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

Novan Reports Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 30, 2023
Rosacea, EPI, Satō, Drug development, SG, File, Marketing, Novin, NDA, Health, Nitric oxide, Research, Research and development, Development, Acquisition, Molluscum contagiosum, PDUFA, Webcast, SB206, Growth, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Conference, Food, Pharmaceutical industry, Cryptocurrency, Video game, Dermatology

DURHAM, N.C., March 30, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its financial and operating results for the full year ended December 31, 2022 and provided a corporate update. The Company will host a conference call and webcast, today, March 30, 2023, at 8:30 a.m. ET (details below).

Key Points: 
  • ET –
    DURHAM, N.C., March 30, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its financial and operating results for the full year ended December 31, 2022 and provided a corporate update.
  • As of December 31, 2022, Novan had a total cash and cash equivalents balance of $12.3 million.
  • Novan reported total revenue of $23.7 million and $3.0 million for the year ended December 31, 2022 and 2021, respectively.
  • 61% growth in 2022 compared to 2021;
    68% growth in fourth quarter 2022 compared to fourth quarter 2021; and
    13% decrease in fourth quarter 2022 compared to third quarter 2022.

Novan Announces Closing of $6.0 Million Registered Direct Offering

Retrieved on: 
Thursday, March 16, 2023
Sale, Novin, Exercise, Telephone, SB206, Prospectus, Security (finance), Park Avenue, 3rd Floor

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Key Points: 
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • The gross proceeds to Novan from this offering are approximately $6.0 million, before deducting the placement agent’s fees and other offering expenses payable by Novan.
  • The offering was made only by means of a prospectus supplement and accompanying prospectus that forms a part of the registration statement.
  • A prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC and may be obtained for free on the SEC’s website located at http://www.sec.gov.

Novan Announces $6.0 Million Registered Direct Offering

Retrieved on: 
Tuesday, March 14, 2023
Sale, Novin, Exercise, Telephone, SB206, Prospectus, Security (finance), Park Avenue, 3rd Floor

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Key Points: 
  • H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
  • The gross proceeds to Novan from this offering are expected to be approximately $6.0 million, before deducting the placement agent’s fees and other offering expenses payable by Novan.
  • The offering is expected to close on or about March 16, 2023, subject to satisfaction of customary closing conditions.
  • A prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC and, when available, may be obtained for free on the SEC’s website located at http://www.sec.gov.

Novan Moves Forward with Unified Corporate Branding

Retrieved on: 
Wednesday, March 8, 2023
Drug development, EPI, Novin, Dermatology, SB206, Organization, Health, United Brands Company v Commission of the European Communities, Marketing, Acquisition, Pharmaceutical industry

DURHAM, N.C., March 08, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that its commercial subsidiary, EPI Health, will now unify under one brand name, Novan.

Key Points: 
  • – EPI Health adopts Novan corporate branding, creating unified identity in advance of potential commercial launch of berdazimer gel, 10.3% (SB206) –
    DURHAM, N.C., March 08, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that its commercial subsidiary, EPI Health, will now unify under one brand name, Novan.
  • “Since the closing of our acquisition of EPI Health in March of 2022, we have made significant progress integrating our organizations into one cohesive business.
  • As of today, we are pleased to move forward as one united brand, Novan, with the unified goal of building a premier medical dermatology company.
  • We believe our integrated business will streamline our pre-commercial activities for berdazimer gel, 10.3%,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum with a PDUFA Goal Date of January 5, 2024

Retrieved on: 
Tuesday, March 7, 2023
Prescription Drug User Fee Act, Novin, Dermatology, FDA, NDA, Molluscum contagiosum, SB206, Marketing, New chemical entity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, File, Food, Pharmaceutical industry

DURHAM, N.C., March 07, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that the U.S. Food and Drug Administration (“FDA”) accepted for filing Novan’s New Drug Application (“NDA”) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum (“molluscum”). The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.

Key Points: 
  • The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.
  • “The opportunity for our NDA to be approved in less than 10 months from today marks a significant and important milestone for Novan and its shareholders.
  • We believe our NCE can provide a much-needed therapeutic option for molluscum patients with the added benefit of being an easily applied, topical, self-administered treatment,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.
  • Novan’s commercial infrastructure includes a highly experienced sales and marketing team, supply chain capabilities, market access knowledge, medical affairs experts, and a network of related partners.