VYNE Therapeutics Inc (VYNE)

[realfast95]

VYNE Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

VYNE Therapeutics Inc.
Thu, May 6, 2021, 7:00 AM·19 min read

Conference call and live webcast today at 8:30 am Eastern Time

BRIDGEWATER, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced financial results for the first quarter ended March 31, 2021 and provided a corporate update.

“Our sales organization continues to drive utilization of AMZEEQ and ZILXI, with prescriptions for both products gaining momentum,” said David Domzalski, Chief Executive Officer of VYNE Therapeutics. “During the first quarter, we unveiled our newest candidate FMX114, a combination topical gel product candidate for the treatment of mild-to-moderate atopic dermatitis. We plan to take FMX114 into a Phase 2a study in the third quarter, with top-line results expected before year end.”

First Quarter and Recent Highlights:

FDA approved AMZEEQ® (minocycline) label update to include new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. acnes”) to develop resistance to minocycline

Announced development program for FMX114, a combination topical gel for mild-to-moderate atopic dermatitis (AD)

FMX114 is a fixed combination of tofacitinib (pan-JAK inhibitor) and fingolimod (sphingosine 1-phosphate receptor modulator) designed to address the multi-factorial nature of AD

Phase 2a clinical study in AD expected to begin in 3Q 2021 with top-line results expected by year end

Proof of concept demonstrated in an animal model of AD

Raised $73.1 million net proceeds from a registered direct offering of common stock and through utilization of an at-the-market equity offering program

Executed 1-for-4 reverse stock split



Financial Performance
(in thousands, except per share amounts)


Three Months Ended March 31,


2021


2020

Total Revenues


$


4,119


$


1,750


Net Loss


$


(20,550


)


$


(40,233


)

Diluted Net Loss per Share


$


(0.42


)


$


(3.79


)

Adjusted Net Loss*


$


(18,108


)


$


(38,474


)

Adjusted Diluted Net Loss per Share*


$


(0.37


)


$


(3.62


)

Adjusted EBITDA*


$


(17,024


)


$


(37,346


)

* See "Note Regarding the Use of Non-GAAP Financial Measures" elsewhere in this earnings release.

Financial Results for the First Quarter Ended March 31, 2021

Revenues
Revenues totaled $4.1 million for the three months ended March 31, 2021 compared to $1.8 million for the three months ended March 31, 2020. For the three months ended March 31, 2021, our revenue consisted of $3.9 million of product sales, and $0.2 million of royalty revenue. For the three months ended March 31, 2020, revenues consisted solely of $1.8 million of product sales.

The increase in product sales is due to the ZILXI product launch in October 2020 and increase in demand for AMZEEQ.

Cost of Goods Sold
Cost of goods sold was $0.6 million for the three months ended March 31, 2021 compared to $0.3 million for the three months ended March 31, 2020. The increase in cost of goods sold is primarily due to an increase in sales volume.

Our gross margin percentage was 85% for both the three months ended March 31, 2021 and March 31, 2020.

Research and Development Expenses
Our research and development expenses for the three months ended March 31, 2021 were $6.3 million, representing a decrease of $9.6 million, or 60.3%, compared to $16.0 million for the three months ended March 31, 2020. Employee-related expenses decreased $5.2 million primarily due to severance costs incurred in 2020 due to the merger with Foamix Pharmaceuticals Ltd. (the "Merger"). Clinical trial and manufacturing expenses decreased with the completion of FCD 105 and serlopitant clinical trials and the product launches of AMZEEQ and ZILXI during 2020.

Selling, General and Administrative Expenses
Our selling, general and administrative expenses for the three months ended March 31, 2021 were $16.6 million, representing a decrease of $8.8 million, or 34.6%, compared to $25.4 million for the three months ended March 31, 2020. Employee-related expenses decreased by $6.1 million primarily due to severance costs incurred in 2020 due to the Merger. Professional services spend decreased as these expenses were incurred in 2020 as a result of the Merger.

Total operating expenses adjusted for stock based compensation*
Set forth below is a presentation of our total operating expenses for the three months ended March 31, 2021, adjusted to exclude certain non-cash expenses incurred during the period. The adjustments below reflect non-cash expenses of stock based compensation. We believe that the adjusted operating expenses are important measures as they better reflect the ongoing operations of the Company and exclude certain non-cash expenses.


(in thousands)


Reported for the three months ended
March 31, 2021


Adjustments


Adjusted for the three months ended
March 31, 2021

Research and development


6,333


(458


)


5,875

Selling, general and administrative


16,616


(1,984


)


14,632

Total operating expenses


22,949


(2,442


)


20,507

* Adjusted results are non-GAAP financial measures. See "Note Regarding the Use of Non-GAAP Financial Measures" elsewhere in this earnings release.

Cash & Cash Equivalents
As of March 31, 2021, VYNE had cash, cash equivalents, restricted cash and investments of $120.4 million. Cash used in operations was $12.6 million. We believe that our existing cash, cash equivalents and investments as of March 31, 2021 and projected cash flows from revenues will provide sufficient resources to fund its current ongoing needs for at least the next twelve months. See VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 for additional discussion on liquidity.

Conference Call and Live Webcast
VYNE management will host a conference call and live webcast today, Thursday, May 6, 2021, at 8:30 am Eastern Time to discuss the financial results and provide a business update.

Toll Free:


800-909-4985

International:


312-281-1211

Conference ID:


21993618

Webcast:


http://public.viavid.com/index.php?id=144542

A replay of the call will be archived on the Company’s website at www.vynetherapeutics.com promptly after the conference call.

Note Regarding the Use of Non-GAAP Financial Measures

The Company has provided certain non-GAAP financial information as additional information to measure operating performance, including, among others, Adjusted Total Operating Expenses, Adjusted Net Loss, Adjusted Diluted Net Loss per Share and Adjusted EBITDA. The Company believes that its presentation of such non-GAAP measures provides useful information to management and investors regarding its financial condition and operations. Specifically, these measures exclude, among other things, share-based compensation. The Company does not believe that such expenses accurately reflect the Company's ongoing operations, and the Company does not expect to incur similar expenses in future periods. These measures are not in accordance with, or an alternative for, generally accepted accounting principles in the United States (“GAAP”) and may be different from similarly titled non-GAAP measures reported by other companies. The Company has provided required reconciliations to the most comparable GAAP measures elsewhere in the document.