# EDGAR Filing Document

**Accession Number:** 0001467154
**File Stem:** 0001467154-23-000005
**Filing Date:** 2023-1
**Character Count:** 43055
**Document Hash:** 888a292629eb5e0845deec81882f2b74
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001467154-23-000005.hdr.sgml**: 20230106

**ACCESSION NUMBER**: 0001467154-23-000005

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 40

**CONFORMED PERIOD OF REPORT**: 20230106

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230106

**DATE AS OF CHANGE**: 20230106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Novan, Inc.
- **CENTRAL INDEX KEY:** 0001467154
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 204427682
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37880
- **FILM NUMBER:** 23513780

**BUSINESS ADDRESS:**
- **STREET 1:** 4020 STIRRUP CREEK DRIVE, SUITE 110
- **CITY:** DURHAM
- **STATE:** NC
- **ZIP:** 27703
- **BUSINESS PHONE:** 919-485-8080

**MAIL ADDRESS:**
- **STREET 1:** 4020 STIRRUP CREEK DRIVE, SUITE 110
- **CITY:** DURHAM
- **STATE:** NC
- **ZIP:** 27703

?xml version="1.0" ? novn-20230106

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

 **CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

Date of report (Date of earliest event reported): **January 6, 2023**

_____________________

**Novan, Inc.**

(Exact name of registrant as specified in its charter)

_____________________

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| | | |
|:---|:---|:---|
| **Delaware** | **001-37880** | **20-4427682** |
| (State or other jurisdiction of<br>incorporation) | (Commission<br>File Number) | (IRS Employer<br>Identification No.) |

---

**4020 Stirrup Creek Drive, Suite 110, Durham, North Carolina 27703**

(Address of principal executive offices) (Zip Code)

**(919) 485-8080**

(Registrant's telephone number, including area code)

**N/A**

(Former name or former address, if changed since last report)

_____________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **<u>Title of Each Class</u>** | **<u>Trading Symbol(s)</u>** | **<u>Name of Each Exchange on Which Registered</u>**  |
| Common Stock, $0.0001 par value | NOVN | The Nasdaq Stock Market LLC |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 8.01. Other Events.**

On January 6, 2023, Novan, Inc. (the "Company") issued a press release announcing the submission of a New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum. The full text of the Company's press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On January 6, 2023, the Company also published a corporate presentation on its website at www.Novan.com. The corporate presentation is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

**Item 9.01. Financial Statements and Exhibits.**

 (d) Exhibits

**EXHIBIT INDEX**

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press Release dated January 6, 2023](a1062023exhibit991.htm)</u> |
| 99.2 | <u>[Corporate Presentation (January 2023)](novn_corporatepresentati.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

*The inclusion of any website address in this Form 8-K, and any exhibit thereto, is intended to be an inactive textual reference only and not an active hyperlink. The information contained in, or that can be accessed through, such website is not part of or incorporated into this Form 8-K.*

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
| | **Novan, Inc.** | **Novan, Inc.** |
| Date: January 6, 2023 | By: | /s/ John M. Gay |
|  |  | John M. Gay |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![logoa.jpg](logoa.jpg)

**Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum** 

*– Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and under standard review timelines –*

*– Molluscum contagiosum is a viral skin infection that affects approximately 6 million people, most of them children*<sup>1,2</sup> *–*

*– Berdazimer gel, 10.3% has the potential to be the first FDA-approved prescription product for the treatment of molluscum*<sup>3</sup> *–*

**DURHAM, N.C., January 6, 2023** — Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum ("molluscum"). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.

"Today marks a significant milestone for Novan and the culmination of substantial efforts of the entire Novan team – the Company's first NDA submission. I am extremely proud of our team and the progress thus far with berdazimer gel, 10.3%. Based on the robust data generated from our Phase 3 studies, we believe the product candidate is well-positioned to treat molluscum, which remains an unmet need. The NDA submission brings Novan closer to providing what could be the first FDA-approved prescription product for the treatment of this contagious viral skin infection," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. The active ingredient, berdazimer sodium, is a new chemical entity that releases nitric oxide and has anti-viral activity.<sup>4</sup> If approved, berdazimer gel, 10.3% would be the first effective and safe topical treatment indicated for molluscum with the convenience of self-application.

Results from the pivotal Phase 3 B-SIMPLE4 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum (NCT04535531) demonstrated highly statistically significant improvement in primary clinical endpoint (p<0.0001) in the largest cohort of molluscum patients ever studied and were recently published in *JAMA Dermatology*.<sup>3</sup> Berdazimer gel, 10.3% was found to be well tolerated with mild application site pain and mild to moderate erythema reported as the most common adverse events.<sup>3</sup>

"Many patients with molluscum go untreated due to a lack of FDA-approved therapeutic options. A topical gel applied by the patient or caregiver that has the potential to clear molluscum lesions and is well tolerated would likely be a significant change to clinical practice. Right now, we are limited to in-office procedures to treat this bothersome infection. I think caregivers and patients with molluscum would welcome berdazimer gel as a breakthrough in treatment. I look forward to the potential of having this option available for my patients," said Adelaide Hebert, M.D., Chief

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of Pediatric Dermatology at McGovern School of Medicine and Children's Memorial Hermann Hospital.

**About Berdazimer**

Berdazimer sodium, the active ingredient in berdazimer gel, 10.3% (SB206), is a new chemical entity. Berdazimer gel, 10.3% for the treatment of molluscum contagiosum is a potential first-in-class topical nitric oxide-releasing agent with positive Phase 3 data submitted to the FDA. Berdazimer gel, 3.4% (SB204), a topical monotherapy in Phase 3 clinical development for the treatment of acne, utilizes the same active ingredient as berdazimer gel, 10.3% and is formulated specifically to address acne.

**About Molluscum**

Molluscum contagiosum is a common, contagious viral skin infection caused by the *molluscipoxvirus*,<sup>5</sup> affecting approximately six million people in the U.S.,<sup>1,2</sup> with the greatest incidence in children aged one to 14 years.<sup>6</sup> Infected children typically present with 10 to 30 unsightly lesions,<sup>7</sup> and in severe cases, they can have around 100 lesions,<sup>8</sup> mostly clustering on the face, trunk, limbs and axillary areas.<sup>7</sup> Over 70% of molluscum patients go untreated.<sup>9,10</sup> There are no FDA-approved therapies for molluscum, with current treatments limited to potentially painful in-office, healthcare provider-administered physical procedures or cantharidin, or off-label prescriptions and over-the-counter products.<sup>7,11</sup> Molluscum may take a long time to resolve, with lesions persisting 13 months to 5 years,<sup>11,12</sup> and transmission of this highly-contagious virus is common, spreading to other children through direct skin contact or sharing contaminated objects like towels.<sup>13</sup> In-household transmission to other children is reported around 41%.<sup>12</sup> Despite the prevalence and high transmissibility, there is a significant unmet need in the molluscum treatment landscape.

**About Novan**

Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates where there are unmet medical needs. We are developing berdazimer gel, 10.3% (SB206) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum.

Novan completed the acquisition of EPI Health in early 2022. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams, promoting products for plaque psoriasis, rosacea, acne and dermatoses. Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

**Forward-Looking Statements**

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," "look forward to" and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the timing of potential FDA acceptance and

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approval of the Company's NDA for berdazimer gel, 10.3% (SB206) for molluscum contagiosum, the therapeutic value and benefits of the Company's Nitricil™ platform technology and its product candidates, including berdazimer gel, 10.3% (SB206), and the potential market opportunity for the Company's product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach in its NDA submission for berdazimer gel, 10.3% (SB206) for molluscum contagiosum or any future NDA submissions, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to extend its cash runway or to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals for and launching products developed internally and its ability to recruit and retain qualified personnel and key talent; changes in the size and nature of the market for the Company's product candidates and promoted products, including potential competition, patient and payer perceptions and reimbursement determinations; risks and uncertainties in the Company's ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company's product candidates, or that any of the Company's product candidates, if approved, will continue to demonstrate requisite safety and efficacy following their commercial launch; any operational or other disruptions as a result of the COVID-19 pandemic and related or unrelated constraints on the global workforce; risks related to the manufacture of raw materials and finished drug product, such as supply chain disruptions or delays, potential price increases, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the Company's facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and its development, manufacturing and commercialization efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company's product candidates and the operation of its business on terms that are acceptable to the Company or at all or if such relationships or transactions are unsuccessful or the Company is unable to realize the potential economic benefits of such relationships or transactions; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2021, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and the Company disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

**INVESTOR AND MEDIA CONTACT:**

Jenene Thomas

JTC Team, LLC

833-475-8247

<u>NOVN@jtcir.com</u>

References:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.About Molluscum. Accessed December 29, 2022. https://aboutmolluscum.com/

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.Global molluscum contagiosum epidemiology forecast to 2028 December 16, 2019. Accessed December 29, 2022. https://www.businesswire.com/news/home/20191216005378/en/Global-Molluscum-Contagiosum-Epidemiology-Forecast-to-2028---ResearchAndMarkets.com

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.Browning JC, Enloe C, Cartwright M, et al. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. *JAMA Dermatol*. 2022;158(8):871-878.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.Banerjee NS, Moore DW, Wang HK, Broker TR, Chow LT. NVN1000, a novel nitric oxide-releasing compound, inhibits HPV-18 virus production by interfering with E6 and E7 oncoprotein functions. *Antiviral Res.* 2019;170:104559.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.Chen X, Anstey AV, Bugert JJ. Molluscum contagiosum virus infection. *Lancet Infect* Dis. 2013;13(10):877-888.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.Schofield JK, Fleming D, Grindlay D, Williams H. Skin conditions are the commonest new reason people present to general practitioners in England and Wales. *Br J Dermatol*. 2011;165(5):1044-1050.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.Badri T, Gandhi GR. Molluscum Contagiosum. [Updated 2022 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441898/ Accessed December 29, 2022.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.Viral Diseases. In: James, William D ed. Andrews' Diseases of the Skin. 13<sup>th</sup> edition. London, UK: Elsevier; 2020: 362-420.e8.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.Syneos. Medical and Pharmacy Benefits Claims, Syneos Insights Suite, 2022.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. *Pediatr Dermatol*. 2015;32(3):353-357.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.American Academy of Dermatology. Molluscum contagiosum: Diagnosis and treatment. Accessed December 29, 2022. https://www.aad.org/public/diseases/a-z/molluscum-contagiosum-treatment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. *Lancet Infect Dis*. 2015;15(2):190-195.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.Meza-Romero R, Navarrette-Dechent C, Downey C. Molluscum contagiosum: an update and review of new perspectives in etiology, diagnosis, and treatment. *Clin Cosmet Investig Dermatol*. 2019;12:373-81.

## Exhibit 99.2

![](novn_corporatepresentati001.jpg)

Innovative Therapies for Skin Diseases N A S D A Q : N O V N \| n o v a n . c o m C O R P O R AT E P R E S E N TAT I O N / J A N UA R Y 2 0 2 3 Exhibit 99.2

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![](novn_corporatepresentati002.jpg)

NOVAN.COM FORWARD-LOOKING STATEMENTS 2 This presentation contains forward-looking statements including, but not limited to, statements related to the timing of potential FDA approval of the Company's new drug application (NDA) for berdazimer gel, 10.3% (SB206) for molluscum contagiosum, pricing and reimbursement considerations, the therapeutic value and benefits of the Company's promoted products, the potential therapeutic value and benefits of the Company's Nitricil™ platform technology and its product candidates, the potential market opportunity for the Company's product candidates and promoted products, including patient, health care provider and payer perceptions, the Company's pharmaceutical development of nitric oxide-releasing product candidates, the availability of potential financing options and the Company's expected cash runway. These forward-looking statements are included throughout this presentation, and the Company uses the words "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks related to the acquisition of EPI Health; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach in its NDA submission for berdazimer gel, 10.3% (SB206) for molluscum contagiosum or any future NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to extend its cash runway or to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals for and launching products developed internally and its ability to recruit and retain qualified personnel and key talent; changes in the size and nature of the market for the Company's product candidates and promoted products, including potential competition, patient and payer perceptions and reimbursement determinations; the Company's ability to grow revenues from promoted products and the risks that past performance may not be indicative of future performance; risks and uncertainties in the Company's ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company's product candidates, or that any of the Company's product candidates, if approved, will continue to demonstrate requisite safety and efficacy following their commercial launch; any operational or other disruptions as a result of the COVID-19 pandemic and related or unrelated constraints on the global workforce; risks related to the manufacture of raw materials and finished drug product, such as supply chain disruptions or delays, price increases, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the Company's facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and its development, manufacturing and commercialization efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company's product candidates and the operation of its business on terms that are acceptable to the Company or at all or if such relationships or transactions are unsuccessful or the Company is unable to realize the potential economic benefits of such relationships or transactions; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2021, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this presentation, and the Company disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of or that any independent source has verified, any information obtained from third-party sources.

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![](novn_corporatepresentati003.jpg)

Building a premier medical dermatology company focused on developing and commercializing innovative therapeutic products for skin diseases

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![](novn_corporatepresentati004.jpg)

NOVAN.COM INVESTMENT HIGHLIGHTS 4 Anticipating FDA approval in first quarter 2024 (following a typical 12-month review) Potential to be the first FDA-approved prescription product for molluscum Commercial infrastructure ready to launch berdazimer gel, 10.3%, if approved U.S. market potential of ~6 million patients1 with no currently approved treatment Expecting favorable access with payors for a novel prescription treatment Submitted NDA for Berdazimer Gel, 10.3% (SB206) for Treatment of Molluscum Contagiosum to U.S. FDA on January 5, 2023 1. Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6).

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![](novn_corporatepresentati005.jpg)

NOVAN.COM BERDAZIMER GEL, 10.3% (SB206) 51. 2023 Berdazimer gel 10.3% New Drug Application Novan. 2023. 2. Browning JC, Enloe C, Cartwright M, et al. JAMA Dermatol. 2022;158(8):871-878. 3.Cartwright M, Enloe C, Stripling S, Maeda-Chubachi T. J Drugs Dermatol. 2022;21(10):1104-1110. NOTES: B-SIMPLE4 is a pivotal Phase 3 study. B-SIMPLE1 & B-SIMPLE2, also Phase 3 studies, will be integrated to support B-SIMPLE4 in the NDA. B-SIMPLE3 was a Phase 1, Maximum-Use PK study in patients. Demonstrated clinical evidence of efficacy and a favorable safety profile across the Phase 3 program1 Robust clinical data including primary efficacy endpoint (p<0.0001) versus vehicle1 A rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum Applied once daily to the top of all lesions (up to 12 weeks) Novel topical nitric oxide- releasing medication Results published in JAMA Dermatology in July 2022 Submitted NDA for Treatment of Molluscum to U.S. FDA

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![](novn_corporatepresentati006.jpg)

NOVAN.COM Market Primed for a Topical Self-Administered Therapy 6 Significant impact on quality-of-life for patients and caregivers1 Current therapies are cumbersome and potentially painful in-office procedures2 Caregivers and physicians are aligned in desire for effective prescription treatment1 Molluscum Contagiosum 1. Browning JC, Cartwright M, Thorla I Jr, et al. Am J Clin Dermatol. 2022;10.1007/s40257-022-00733-9. 2. van der Wouden JC, van der Sande R, Kruithof EJ, et al. Cochrane Database Syst Rev. 2017;5:CD004767

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![](novn_corporatepresentati007.jpg)

NOVAN.COM HIGHLY CONTAGIOUS SKIN INFECTION Molluscum is caused by the molluscipoxvirus, a double-stranded DNA virus 1. Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6). 2. Molluscum Contagiosum - Epidemiology Forecast – 2028. Seven Major Markets (U.S., Germany, Spain, Italy, France, the United Kingdom, and Japan from 2017 – 2028). 3. Syneos Health market research sponsored by Novan, Inc. 7 Affects approximately ~6 million people in the U.S.1,2 Causes round, firm, itchy bumps / lesions More than 1 million new cases diagnosed annually3 Primarily affects children below the age of 14 Lasts an average of 13 months, if left untreated

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![](novn_corporatepresentati008.jpg)

NOVAN.COM MOLLUSCUM IMPACTS DAILY LIVES 8Source: Syneos Health, Digital ethnography research, July – September 2022 (n=13) Molluscum can create changes in how children see themselves, making them more nervous, cautious, or negatively conscious of their body Molluscum can limit children's social development, creating feelings of isolation and limiting the activities they can participate in Molluscum can feel like a losing battle, creating the feeling of being trapped in a hopeless cycle that seems like it will never resolve Dealing with molluscum can take its toll on daily life, affecting children's ability to fully participate in activities Molluscum and its current treatments can cause damage to the skin and permanent scarring Impact on Self-Identity Social Impact Emotional Impact Functional Impact Physical Impact & Symptoms Negatively Affects Children, Caregivers, and Families

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![](novn_corporatepresentati009.jpg)

NOVAN.COM MARKET RESEARCH INDICATES CURRENT "LACK OF" TREATMENT We Believe Lack of At-Home Therapeutic Option Results in Many Undiagnosed Cases1 9 Select HCPs Treatment Regimens PEDIATRICIAN 0.8% 8% 91% Referrer Treater Wait & See % Peds % ALL MC Patients 67% 4% <1% DERMATOLOGIST 0.2% 65% 35% Referrer Treater Wait & See % Derms % ALL MC Patients 5% 13% <1% 1. Syneos Health market research sponsored by Novan, Inc. (based on 35,000 pediatricians with 187,000 molluscum patients; and 7,000 dermatologists with 48,000 molluscum patients).

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![](novn_corporatepresentati010.jpg)

NOVAN.COM CURRENT TREATMENTS CAN BE PAINFUL OR INEFFECTIVE Over 70% of Molluscum Patients go Untreated1,2 1. Syneos Health market research sponsored by Novan, Inc. 2. Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol. 2015;32(3):353-357. 10 Potentially Painful In-Office Procedures Cryotherapy Pain and Scarring Curettage Pain and Scarring Burning Pain and Scarring Off-Label Drugs Limited Efficacy Natural Remedies Unproven Efficacy Non-FDA Approved

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![](novn_corporatepresentati011.jpg)

NOVAN.COM THE NEED FOR NEW TREATMENT OPTIONS High Demand from HCPs for Novel Treatment Solution 11Source: Syneos Health HCP Survey Results, August 2022. Q5. How would you rate the level of need for new drug therapy options for molluscum, on a scale of 1-7, where 1=no/minimal need and 7=very high need? 1% 5% 7% 14% 40% 24% 9% HC P Co un t (%) Need for New MC Treatment (N=142) Average Need 5.0 1 2 3 4 5 6 7 Low Need (1-3) High Need (6-7) 18% 3% 20% 7% 42% 71% 48% 63% 40% 26% 32% 30% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Peds Derms Ped Derms NPPAs HC P Co un t (%) Need for a New MC Treatment by HCP Population Low Need Moderate Need High Need AVG = 4.9 n = 50 AVG = 5.1 n = 31 AVG = 4.8 n = 31 AVG = 5.0 n = 30 Moderate Need (4-5) Peds exhibit greatest polarity

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NOVAN.COM WILLING TO PRESCRIBE BERDAZIMER GEL, 10.3% 1. Source: Syneos Health HCP Survey Results, August 2022. Q6. Assume Berdazimer 10.3% Gel is approved by the FDA for molluscum. How would you rate your willingness to prescribe Berdazimer 10.3% Gel for molluscum on a scale of 1-7 (1=very low/unwilling and 7=very high/very willing)? 12 1% 1% 6% 18% 31% 27% 16% HC P Co un t (%) Willingness to Prescribe Berdazimer Gel, 10.3% (N=142) 1 2 3 4 5 6 7 10% 13% 6% 3% 56% 45% 48% 40% 34% 42% 46% 57% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Peds Derms Ped Derms NPPAs HC P Co un t (%) Willingness to Prescribe Berdazimer Gel, 10.3% by HCP Population Low Willingness Moderate Willingness High Willingness AVG = 5.0 n = 50 AVG = 5.2 n = 31 AVG = 5.2 n = 31 AVG = 5.7 n = 30 Low Willingness (1-3) High Willingness (6-7) Moderate Willingness (4-5) Average Willingness 5.2 Overwhelming Majority of HCPs are Interested in Novan's Novel Treatment Solution

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NOVAN.COM PAYER, PRICING AND REIMBURSEMENT1 , 2 1. Source: Syneos Health, Active Payer Primary Research, August 2022 (n=6) 2. Final pricing decisions may be made by Novan after due consideration of commercial, clinical, and legal factors. Syneos Health Consulting's information, provided here, represents information gathered primarily from third parties to inform Novan's decision and does not represent final pricing. 13 Current Management of Molluscum Contagiosum Limited-to-no management of molluscum contagiosum due to lack of FDA approved therapeutic options Payers acknowledged lack of visibility into drugs or medical procedures Payers may be more favorably disposed to give access to a new product for pediatric patients No At-Home Prescription Treatment Option✓ Molluscum is a Contagious Viral Infection✓ Primarily Affects Children✓ Expectation for a New Product and Reaction to Berdazimer TPP Most payers rated berdazimer gel, 10.3% highly (average rating of 5.1 on a scale of 1–7) First FDA approved drug in this space was cited as the primary advantage, if approved Anticipated Access Step edits and non coverage were unlikely due to lack of FDA approved therapeutic options No notable differences were suggested for access controls in commercial vs Medicaid book of business Berdazimer Gel, 10.3% is Aligned with Payer Reimbursement Criteria

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NOVAN.COM PLANNING FOR COMMERCIAL SUCCESS 14 Anticipating FDA Approval in Q1 2024 (following a typical 12-month review) Building awareness and excitement among dermatologist and pediatricians Educating on molluscum treatment vs. commonly used "watch and wait" Delivering best possible managed care coverage and patient access program Optimizing and readying commercial organization Strong U.S. IP protection based on proprietary platform technology

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NOVAN.COM Commercial Product Portfolio 15

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NOVAN.COM COMMERCIAL CAPABILITIES 16 Established Presence Across the Dermatology Community ✓ Supply Chain And Market Access Well established dermatology specialty pharmacy network Comprehensive market access (payor strategy, patient assistance copay program) Established supply chain with 3rd party contract manufacturers (CMOs) ✓ Marketing Leadership team with decades of relevant dermatology experience Recent significant launches: Wynzora, Rhofade, Minolira, Cloderm Strong KOL relationships ✓ Sales Team 42 territories across the U.S. Solid engagement with ~4,000 HCPs1 Dedicated to three of the most prevalent medical dermatological conditions2 Ready to support potential approval and launch of Berdazimer Gel, 10.3% 1. Based on average quarterly activity for 2022. 2. American Academy of Dermatology. Skin conditions by the numbers. https://www.aad.org/media/stats-numbers

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NOVAN.COM DELIVERED YEAR-OVER-YEAR GROWTH ACROSS PROMOTED PRODUCTS1 1. Source: IQVIA's SMART Database – U.S. Edition 2. Commercial launch in the United States in Q3 2021 17 Q3 2022 TRx's 37,900 10,085 12,417 Q3 YTD 2022 TRx's 115,873 31,059 29,880 2021 TRx's 117,436 10,033 25,213 YTD Q3'21 vs. Q3 22 Growth 37% __ 2 59% Q3'21 vs. Q3'22 Growth 31% 216%2 78%

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NOVAN.COM 1: IQVIA National Prescription Audit, Moving Annual Total November 2022; 2: "Understanding Rosacea." Rosacea.org, accessed 10 Jan. 2022, https://www.rosacea.org/patients/materials/understanding-rosacea/what-is-rosacea; 3: Del Rosso JQ. Advances in understanding and managing rosacea: part 1: connecting the dots between the pathophysiological mechanisms and common clinical features of rosacea with emphasis on vascular changes and facial erythema. J Clin Aesthet Dermatol. 2012;5(3):16-25.; 4: Huynh TT. Burden of disease: the psychosocial impact of rosacea on a patient's quality of life. Am Health Drug Benefits. 2013;6(6):348-354; 5: Eichenfield LF, Del Rosso JQ, Tan JKL, et al. Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1.0% for persistent erythema of rosacea in a phase IV study. Br J Dermatol. 2019;180(5):1050-1057.; 6: Draelos ZD, Gold MH, Weiss RA, et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 52-week open label REVEAL trial. J Am Acad Dermatol. 2018;78(6):1156-1163. 18 #1 Prescribed for the Treatment of Persistent Facial Erythema1 (Facial Redness) 31% Growth vs 3Q Prior YearHighlights: • Vascular dysregulation is the primary cause of persistent facial erythema (PFE) in rosacea patients • Often left untreated, PFE can worsen and changes can become permanent1,3,4 • Rhofade works quickly and lasts all day • Visible reduction in redness as early as 1 hour5 • Improvement persists with regular daily use over 52 weeks6 Rosacea U.S. Market Overview • ~16 million people in the U.S.2 Potentially expanding into Japan through License Agreement with Sato Pharmaceuticals Co. 19,565 23,997 25,208 30,714 28,931 32,583 37,154 40,819 37,900 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 TRx Growth Quarter Over Quarter

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NOVAN.COM 1. Wynzora® Cream [package insert]. MC2 Therapeutics; 2020; 2. Præstegaard M, Vestbjerg B, Selmer J, Holm-Larsen T. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62; 3. US Department of Health and Human Services. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. 41st ed. US Government Publishing Office; 2021. https://www.fda.gov/media/71474/download. Accessed June 24, 2021; 4. Data on file. MC2 Therapeutics 5. Rachakonda TD et aJ Am Acad Dermatol 2014;70:512-6. 19 Once Daily Topical Treatment Combines the Benefits of a High Potency Steroid Plus Vitamin D for the Treatment of Plaque Psoriasis Highlights: • First and only water-based calcipotriene and betamethasone dipropionate cream1,2,3 • Ideal for patients with localized plaques on their knees, elbows and scalp • Launched in July 2021, Wynzora demonstrates a rapid onset of action with continued improvement at 8 weeks • Visible results as early as 1 week1,4 • 83.6% of trial subjects had at least a 1-grade improvement from baseline at week 82 Psoriasis U.S. Market Overview • ~7.5 million people in the U.S.5 3,194 6,836 9,287 11,687 10,085 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 TRx Growth Quarter Over Quarter 216% Growth vs 3Q Prior Year Based in part to timing of product launch in the United States

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NOVAN.COM 1: Indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older; 2: Minolira PI; 3: Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500; 4: Ward D Jr. Pharmacokinetic implications of a patented delivery system on a new FDA approved biphasic minocycline extended release tablet dosed 1 mg/kg in acne vulgaris. Poster presented at: Dermatology Educational Foundation Essential Resource Meeting; July 18-21, 2019; Las Vegas, NV; 5: Hamman H, Hamman J, Steenekamp J. Multiple-unit pellet system (MUPS): production and applications as advanced drug delivery systems. Drug Deliv Lett. 2017; 7(3):201-210. 20 First Ever Biphasic Delivery System of Minocycline for the Treatment of Acne1 Highlights: • The only delivery technology that offers functional scoring weight-based flexible dosing2 • The safety of sustained-release minocycline with low risk of GI upset4,5 Acne U.S. Market Overview • ~50 million people in the U.S.3 78% Growth vs 3Q Prior Year 100 3,657 4,913 6,930 6,968 6,402 7,342 10,121 12,417 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 TRx Growth Quarter Over Quarter

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NOVAN.COM Corporate Overview 21

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NOVAN.COM PROVEN TEAM WITH EXPERTISE ACROSS DRUG DEVELOPMENT AND COMMERCIALIZATION 22 Paula Brown Stafford, MPH President, Chief Executive Officer and Chairman Tomoko Maeda-Chubachi, MD, Ph.D., MBA Chief Medical Officer Carri Geer, Ph.D. SVP, Chief Technology Officer Brian M. Johnson, MBA Chief Commercial Officer John M. Gay, CPA Chief Financial Officer John Donofrio EVP, Chief Operating Officer; President, EPI Health

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NOVAN.COM FINANCIAL SNAPSHOT 23 1. With the December 2022 activity noted, the Company believes that its existing cash and cash equivalents, plus expected receipts associated with product sales from its commercial product portfolio, will provide it with adequate liquidity to fund its planned operating needs into the end of the first quarter of 2023. Variability in its operating forecast, driven primarily by (i) commercial product sales, (ii) timing of operating expenditures, and (iii) unanticipated changes in net working capital, will impact the Company's cash runway. 2. A portion of the amounts of the upfront payment is payable by EPI Health to a third party under contractual obligations related to Rhofade. Additional Capital Needed for Potential Q1 2024 Launch of Berdazimer gel, 10.3% (SB206) June 2022 Closed a registered direct offering with an institutional investor for $15.0 million July 2022 Satisfied $16.5 million debt related to EPI Health acquisition for $10 million, saving cash from the reduced principal and $4.6 million in scheduled interest payments December 20221 Leveraged commercial accounts receivable for $15.0 million factoring facility to support working capital & Signed initial ex-U.S. out-licensing agreement for Rhofade, including an upfront payment of $5.0 million2 Recent Execution on Financing Strategies Despite a Challenging Market $14.9 million Cash as of September 30, 2022

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NOVAN.COM 24 FOCUS GOING FORWARD Building a premier medical dermatology company focused on developing and commercializing innovative therapeutic products for skin diseases Driving towards potential approval of berdazimer gel, 10.3% (SB206) for treatment of molluscum in Q1 2024 Aligning commercial infrastructure to support potential launch of berdazimer gel, 10.3% Continuing growth of marketed medical dermatology products (Wynzora, Rhofade, Minolira) Pursuing additional ex-U.S. out-licensing opportunities, in addition to our recent Sato agreement for Japan

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Innovative Therapies for Skin Diseases N A S D A Q : N O V N \| n o v a n . c o m Thank You!

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