8-K

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 and Exchange Act of 1934

Date of report (Date of earliest event reported): November 7, 2018

FOAMIX PHARMACEUTICALS LTD.

(Exact name of registrant as specified in its charter)

Israel	001-36621	N/A
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

	2 Holzman Street, Weizmann Science Park
	Rehovot, Israel	7670402
	(Address of principal executive offices)	(Zip Code)
+972-8-9316233
(Registrant’s telephone number, including area code)

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 (see General Instruction A.2. below):

☐ 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))

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. ☒

Item 2.02. Results of Operations and Financial Condition

On November 7, 2018, Foamix Pharmaceuticals Ltd. (the “Company”) issued a press release announcing its financial results for its third quarter ended September 30, 2018. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information in this Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 7.01.  Regulation FD Disclosure

The Company announced positive topline results from the Company’s Phase III clinical trial of its FMX103 topical minocycline foam for the treatment of moderate-to-severe papulopustular rosacea on Wednesday, November 7, 2018. A copy of the slides presented during the webcast are available on the Company’s website, and are being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information disclosed under this Item 7.01, including Exhibit 99.2 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be incorporated by reference into any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01.  Other Events

On November 7, 2018, the Company issued a press release announcing positive topline results from the FMX103 clinical trial. A copy of the press release is filed herewith as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.  Financial Statements and Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press release of the Company titled “Foamix Reports Third Quarter 2018 Financial Results and Provides Corporate Update,” dated November 7, 2018
99.2	Presentation slides dated November 7, 2018
99.3	Press release of the Company titled “Foamix Announces Positive Topline Results from Phase 3 Program Evaluating FMX103 Topical Minocycline Foam for Moderate-to-Severe Papulopustular Rosacea,” dated November 7, 2018

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.

Date: November 7, 2018

FOAMIX PHARMACEUTICALS LTD.
By:	/s/ Ilan Hadar
	Ilan Hadar
	Chief Financial Officer & Country Manager

EX-99.1

Exhibit 99.1

Foamix Reports Third Quarter 2018 Financial Results and Provides Corporate Update

Conference Call and Webcast Thursday, November 8, @ 8.30 am Eastern Time

Rehovot, Israel, November 7, 2018 – Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) (“Foamix” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today its financial results for the third quarter and nine months ended September 30, 2018.

“We have recently made very substantial progress in the clinic with positive Phase 3 top line data on our two lead programs, FMX101 for the treatment of moderate-to-severe acne, and FMX103 for moderate-to-severe papulopustular rosacea,” said David Domzalski, CEO of Foamix. “The success of these programs provides further validation for our proprietary foam platform and sets us on a path to potentially have 2 products approved within a year of each other. Our clinical and regulatory teams are now focused on completing the necessary steps to prepare regulatory submissions, beginning with a planned NDA for FMX101 in the U.S. before year-end 2018.  We hope to follow this, pending the outcome of the ongoing long-term safety study, with an NDA for FMX103 in 2019.”

Clinical and Corporate Update:

· On November 7^th, announced the topline results from its Phase 3 program evaluating FMX103 1.5% minocycline foam, in the treatment of moderate-to-severe papulopustular rosacea.

o Studies FX2016-11 and FX2016-12 met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (“IGA”) treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.

o FMX103 was found to be generally safe and well tolerated.

o Data from study FX2016-13 evaluating the long-term safety of FMX103 are expected to be reported in the first half of 2019.

o The Company plans to file a New Drug Application (NDA) for FMX103 as a treatment for moderate-to-severe papulopustular rosacea in 2019.

· In September, announced positive topline results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne.

o The study met both co-primary endpoints of: (1) Absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (“IGA”) treatment success at Week 12, with statistical significance.

o The safety profile of FMX101 was found to be consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05).

o The Company expects to file an NDA with the FDA for FMX101 in moderate-to-severe acne by the end of 2018.

· In September, the Company completed a successful public offering in which it issued a total of 13,420,500 ordinary shares, to purchase additional shares. The total net proceeds from the transaction, net of expenses and underwriter commissions, were approximately $75.3 million.

Cash & Investments

At September 30, 2018, the Company had $110.5 million in cash and investments compared to $76.4 million at December 31, 2017. The Company anticipates that with its existing cash and investments we will be able to fund planned operating expenses and capital expenditure requirements through mid-2020. These planned expenses and expenditures include: (a) the full development and filing of an NDA for FMX101, which the Company expects to submit by the end of 2018, (b) completion of its two Phase 3 clinical trials for FMX103, (c) full development and filing of an NDA for FMX103, which the Company expect to submit in 2019, (d) certain pipeline development activities, and (e) certain pre-commercialization and launch preparations for FMX101 towards the end of 2019.

Financial Results for the Third quarter Ended September 30, 2018

Revenues

Revenues decreased by $36,000, or 4.0%, from $901,000 in the three months ended September 30, 2017 to $865,000 in the three months ended September 30, 2018. The change is due to a decrease in development service payments, which was offset by an increase in royalty payments from Bayer and LEO for sales of Finacea.

Operating Expenses

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2018 were $13.1 million, representing a decrease of $2.7 million, or 17.1%, compared to $15.8 million for the three months ended September 30, 2017. The decrease in research and development expenses resulted primarily from a decrease of $3.6 million in costs relating predominantly to FMX101 and FMX103 clinical trials, offset by an increase of $434,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in salary raises, an increase of $139,000 in advisors, consultants and other professional services expenses, and an increase of $120,000 in travel expenses.

Selling, General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2018 were $3.3 million, representing an increase of $376,000, or 13.0%, compared to $2.9 million for the three months ended September 30, 2017. The increase in selling, general and administrative expenses resulted primarily from an increase of $270,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in headcount and salary raises, and an increase of $104,000 in expenses related to the Company’s board of directors.

Net Loss

The loss for the three months ended September 30, 2018 was $15.5 million, or ($0.38) per share, basic and diluted, compared to $17.6 million, or ($0.47) per share, basic and diluted, for the three months ended September 30, 2017, a decrease of $2.1 million.

Financial Results for the Nine Months Ended September 30, 2018

Revenues

Revenues increased by $109,000, or 4.2%, from $2.6 million in the nine months ended September 30, 2017 to $2.7 million in the nine months ended September 30, 2018. The increase is mainly due to increase in royalty payments from Bayer and LEO for sales of Finacea.

Operating Expenses

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2018 were $52.8 million, representing an increase of $10.4 million, or 24.5%, compared to $42.4 million for the nine months ended September 30, 2017. The increase in research and development expenses resulted primarily from (a) an increase of $8.5 million in costs relating predominantly to FMX101 and FMX103 clinical trials, (b) an increase of $2.0 million in payroll and payroll-related expenses, including share-based compensation, primarily due to a change in the measurement of share based compensation expenses of a consultant and an increase in headcount and salary raises, (c) an increase of $504,000 in travel expenses, and (d) an increase of $225,000 in advisors, consultants and other professional services expenses.  Such increases were offset by a decrease of $1.2 million in compensation to one of the company’s co-founders in the nine months ended September 30, 2017.

Selling, General and Administrative Expenses

General and administrative expenses for the nine months ended September 30, 2018 were $10.0 million, representing an increase of $813,000, or 8.8%, compared to $9.2 million for the nine months ended September 30, 2017. The increase in selling, general and administrative expenses resulted primarily from (a) an increase of $1.9 million in payroll and payroll-related expenses, including share-based compensation, mostly due to an increase in headcount, salary raises and accounting modification relating to share based compensation of a consultant, (b) an increase of $512,000 in advisors and other professional services expenses, and (c) an increase of $256,000 in expenses related to the Company’s board of directors. Such increases were offset by (i) a decrease of $1.5 million in compensation to one of the company’s co-founders in the nine months ended September 30, 2017, and (ii) a decrease of $201,000 in travel expenses.

Net Loss

Net loss for the nine months ended September 30, 2018 was $60.1 million, or ($1.50) per share, basic and diluted, compared to a net loss of $48.4 million, or ($1.29) per share, basic and diluted, for the nine months ended September 30, 2017, an increase of $11.7 million.

Conference Call & Webcast Thursday, November 8  @ 8:30am Eastern Time

Toll Free:	866-548-4713
International:	323-794-2093
Conference ID:	3929053
Webcast:	http://public.viavid.com/index.php?id=131716

Replays, Available through November 22:

Toll-Free:	844-512-2921
International:	412-317-6671
Conference ID:	3929053

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

About Foamix

Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including LEO Pharma and others.

Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the Foamix website in addition to following its press releases, filings with the Securities & Exchange Commission (“SEC”), public conference calls, and webcasts.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions created by those sections. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays in clinical trials or announcement of results, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne and dermatology markets, denial of reimbursement by third party payors or inability to raise additional capital, our ability to recruit and retain key employees and our ability to stay in compliance with applicable laws, rules and regulations. We discuss many of these risks in greater detail in our annual and other periodic filings with the SEC, including under the heading “Risk Factors” in our most recent annual report. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Contact:	U.S. Investor Relations
Ilan Hadar, CFO	Michael Rice
Foamix Pharmaceuticals Ltd.	LifeSci Advisors, LLC
+972-8-9316233	646-597-6979
ilan.hadar@foamixpharma.com	mrice@lifesciadvisors.com

Media

Elizabeth Tang, PhD

LifeSci Public Relations

646-863-0222

elizabeth@lifescipublicrelations.com

FOAMIX PHARMACEUTICALS LTD.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. dollars in thousands, except per share data)

(Unaudited)

	September 30, 2018		December 31, 2017
A s s e t s
CURRENT ASSETS:
Cash and cash equivalents	$	87,877	$	15,956
Restricted cash		250		250
Short term bank deposits		6,099		19,443
Investment in marketable securities		15,041		31,797
Restricted investment in marketable securities		277		290
Accounts receivable:
Trade		889		996
Other		1,624		772
TOTAL CURRENT ASSETS		112,057		69,504
NON-CURRENT ASSETS:
Investment in marketable securities		793		8,533
Restricted investment in marketable securities		137		143
Property and equipment, net		2,157		2,042
Other		43		32
TOTAL NON-CURRENT ASSETS		3,130		10,750
TOTAL ASSETS	$	115,187	$	80,254

	September 30, 2018			December 31, 2017
Liabilities and shareholders’ equity
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade	$	5,322		$	6,436
Deferred revenues		-			62
Other		3,714			3,730
TOTAL CURRENT LIABILITIES		9,036			10,228
LONG-TERM LIABILITIES:
Liability for employee severance benefits		379			437
Other liabilities		714			988
TOTAL LONG-TERM LIABILITIES		1,093			1,425
TOTAL LIABILITIES		10,129			11,653
SHAREHOLDERS’ EQUITY:
Ordinary Shares, NIS0.16 par value - authorized: 90,000,000 Ordinary Shares as of September 30, 2018 and December 31, 2017; issued and outstanding: 54,270,174 and 37,498,128 Ordinary Shares as of September 30, 2018 and December 31, 2017, respectively		2,327			1,576
Additional paid-in capital		304,119			208,364
Accumulated deficit		(201,331	)		(141,281	)
Accumulated other comprehensive loss		(57	)		(58	)
TOTAL SHAREHOLDERS’ EQUITY		105,058			68,601
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	115,187		$	80,254

FOAMIX PHARMACEUTICALS LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. dollars in thousands, except per share data)

(Unaudited)

	Nine months ended September 30,						Three months ended September 30,
	2018			2017			2018			2017
REVENUES	$	2,735		$	2,626		$	865		$	901
COST OF REVENUES		-			11			-			11
GROSS PROFIT		2,735			2,615			865			890
OPERATING EXPENSES:
Research and development		52,809			42,400			13,142			15,785
Selling, general and administrative		10,019			9,206			3,309			2,933
TOTAL OPERATING EXPENSES		62,828			51,606			16,451			18,718
OPERATING LOSS		60,093			48,991			15,586			17,828
FINANCE INCOME, net		(471	)		(846	)		(119	)		(302	)
LOSS BEFORE INCOME TAX		59,622			48,145			15,467			17,526
INCOME TAX		463			209			13			57
NET LOSS FOR THE PERIOD	$	60,085		$	48,354		$	15,480		$	17,583
LOSS PER SHARE BASIC AND DILUTED	$	1.50		$	1.29		$	0.38		$	0.47
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS		39,932			37,347			40,873			37,431

EX-99.2

Exhibit 99.2

 Nasdaq: FOMXNovember 2018           

 Forward-Looking Statements and Where to Find More Information  2  To the extent that statements contained in this presentation are not descriptions of historical facts regarding Foamix, they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; (v) the timing or likelihood of regulatory filings and approvals; and (vi) our revenues under our agreements with our licensees, including LEO Pharma and other companies. Although we believe that the expectations reflected in the forward-looking statements are reasonable, various factors may cause differences between our expectations and actual results, including, but not limited to, unexpected safety or efficacy data, unexpected side effects observed during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition, changes in the regulatory environment for our product candidates and our need for future capital, the inability to protect our intellectual property, and the risk that we become a party to unexpected litigation or other disputes. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. You should read the documents filed by Foamix with the SEC, including our most recent annual and quarterly reports and prospectuses, including in each case the Risk Factors set forth therein. You may obtain those documents by visiting EDGAR on the SEC website at www.sec.gov or on our website at www.foamix.com under the heading “Investors.” Foamix uses its website (www.foamix.com) as a channel to distribute information about Foamix and its product candidates. Foamix encourages investors to visit our website from time to time, as information is updated and new information is posted, in addition to following our press releases, SEC filings, public conference calls, and webcasts.The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the foam technology or product candidates of Foamix. 

 FMX103FX2016-11 & FX2016-12Top Line Results  Topical Minocycline Foam 1.5%For Moderate-to-Severe Papulopustular Rosacea  3 

 FMX103 Phase 3 Program Design Studies FX2016-11, FX2016-12 & FX2016-13   4  12-week, randomized, double-blind, vehicle controlled, in subjects with moderate-to-severe papulopustular rosacea; followed by up to an additional 40 weeks open label safety extension  Week 12(End of treatment)  Week 52  Week 4  Week 8      Double-blind Studies(-11,-12)Randomized (2:1), N=750 (X2)    Minocycline Foam 1.5%Foam vehicle    Minocycline foam 1.5% – 9 months of treatment  Open Label Safety Extension Study (-13) Subjects who complete one of the randomized, Phase 3 studies may enter the open-label study  2 US Double-blinded Studies, 100 sites, 1522 enrolled subjects, >18 years of ageSelf-apply, once daily, for 12 weeksInclusion Criteria15 to 75 inflammatory lesions IGA 5 point scale – Moderate to Severe (Grade 3 or 4)Co-primary Efficacy Endpoints:Mean change from Baseline in inflammatory lesion countProportion of subjects with IGA scores of “Clear” or “Almost Clear”, with improvement of at least 2 grades from BaselineSafety Evaluations: AEs, physical exams, vitals, dermal tolerability, labs    BL 

 Rosacea Phase 3 ResultsStudy Metrics, Subject Demographics & Baseline Characteristics  5   Metrics/Demographics  Study 11    Study 12    Subjects Enrolled  751    771    Number of Sites  54    46    Mean Age, yrs  49.2    50.9    Gender, %  M=28.0; F=72.0    M=30.9; F=69.1    Ethnicity, %  W=95.3 B=1.5; O=3.2    W=97.4; B=1.0; O=1.6    Baseline Characteristics (ITT population)  FMX103, 1.5%(N = 495)  Vehicle(N = 256)  FMX103, 1.5%(N = 514)  Vehicle(N = 257)  Baseline Inflammatory Lesion Counts            Mean (SD)  28.5 (12.05)  29.0 (12.13)  30.0 (12.84)  30.2 (12.99)   Median   25  25  26  26  Baseline IGA Score, n (%)            3 – Moderate  444 (89.7)  222 (86.7)  443 (86.2)  213 (82.9)   4 – Severe  51 (10.3)  34 (13.3)  71 (13.8)  44 (17.1) 

 Rosacea Phase 3 Results - EfficacyCo-primary endpoint: Absolute Change of Inflammatory Lesion Count at Week 12  6  In Study 11, absolute change in inflammatory lesion count for the FMX103, 1.5% treatment group was –17.57 versus –15.65 in vehicle treatment group (p=0.0031)In Study 12, absolute change in inflammatory lesion count for the FMX103, 1.5% treatment group was –18.54 versus –14.88 in vehicle treatment group (p<0.0001)   *ANCOVA, ITT population, multiple imputation    P<0.005    P<0.0001  N=XXX  N=XXX  N=XXX  N=XXX  N=495  N=256  N=514  N=257 

 Rosacea Phase 3 Results - EfficacyCo-primary endpoint: IGA Treatment Success at Week 12 [Score Clear (0) or Almost Clear (1)]  In Study 11, IGA Treatment Success for FMX103, 1.5% treatment group was 52.1% versus 43.0% in vehicle treatment group (p=0.027)In Study 12, IGA Treatment Success for FMX103, 1.5% treatment group was 49.1% versus 39.0% in vehicle treatment group (p=0.0077)  *Cochran–Mantel–Haenszel test stratified by analysis center, ITT population, multiple imputation  7    P<0.05  P<0.01    N=738  N=750  N=333  N=162  N=495  N=256  N=514  N=257 

 Rosacea Phase 3 Results - EfficacyKey secondary endpoint: Percent Change of Inflammatory Lesion Count at Weeks 4, 8 and 12  8  ^ANCOVA, Intent to Treat (ITT) Population, Observed Cases  In Study 11, percent change in inflammatory lesion count for the FMX103, 1.5% treatment group at week 12 was -64.13% versus -56.52% in vehicle (p=0.0039) In Study 12, percent change in inflammatory lesion count for the FMX103, 1.5% treatment group at week 12 was -61.45% versus -50.16% in vehicle (p<0.0001) Statistical significance demonstrated at all timepoints (beginning at Week 4) for both studies  ‡P≤.005; †P ≤.001; *P ≤.0001  Study 11  Study 12  *  *  *  †  ‡  -64%  -61%  * 

 Rosacea Phase 3 Results – SafetyTreatment Emergent Adverse Event (TEAE) Frequency   9  Study 11 TEAE Frequency (%)      Study 12 TEAE Frequency (%)      TEAE  FMX103, 1.5%  Vehicle  TEAE  FMX103, 1.5%  Vehicle  One or more  18.4  21.1  One or more  24.1  26.1  URTI  0.8  2.0  URTI  2.9  3.1  Viral URTI  1.8  1.6  Viral URTI  2.9  3.1  UTI  1.0  1.6  Headache  2.1  2.3  Headache  0.6  1.6  Sinusitis  1.4  0.8  Hypertension  1.2  0.8  Influenza  1.0  1.2  Fall  0.0  1.2  Diarrhea  1.2  0.8  Concussion  0.0  1.2  UTI  0.6  1.2        Fatigue  0.4  1.2        Vomiting  1.0  0.4  Non-cutaneous TEAEs in descending frequency occurring in at least 1% of subjects in either group  Study 11 SAEs (FMX103, 1.5%): Nausea, chest discomfort, fatigue, seasonal allergy, dehydration, syncope, dyspnea  Study 12 SAEs (FMX103, 1.5%): Hypertension  No treatment related SAEs were identified in either study.  SAE – Serious Adverse Event; URTI – Upper Respiratory Tract Infection; UTI – Urinary Tract Infection 

 Rosacea Phase 3 Results – Safety Summary   10  The most common systemic adverse event was upper respiratory tract infections in both studies with incidence rates <3% for both FMX103 treatment groups.Treatment area cutaneous TEAEs in the FMX103 treatment groups were few; most were mild and included instances of dermatitis, rash, cyst, pain, pruritus, hyperpigmentation and actinic keratosis.No treatment-related serious adverse events were reported in either study.In total, 9 subjects discontinued in Studies 11 and 12 due to a TEAE including 7 in the FMX103 treatment groups and 2 in the vehicle treatment groups. 

 Rosacea Phase 3 Results – Overall Summary   11  Statistically significant disease improvement of FMX103 vs vehicle was achieved for the co-primary endpoints of absolute reduction of inflammatory lesions and IGA treatment success at Week 12 in both Studies 11 and 12.Treatment emergent adverse events were few in type and frequency; most were mild in severity.No treatment-related serious adverse events were reported.Subject discontinuations due to a TEAE were low in both studies.FMX103 was shown to have a generally favorable safety profile.Study FX2016-13 (open label safety) is currently on-going. 

   Milestones  12    FMX101  FMX103  Non-clinical      Manufacturing scale-up (1-ton)      Phase 3 efficacy      Phase 3 long-term safety    H1 2019  Pre-NDA meeting    H1 2019  NDA Submission  EOY 2018  H2 2019  PDUFA  Q4 2019  H2 2020 

             Commercial Readiness   13        Well-capitalized to support comprehensive launch for FMX101 into 2020  Scientific message platform executionEfficacy and safety dataVehicle valueAnti-resistanceCongress & convention participationPublications   Doryx® Dovonex® Duac®Enstilar®Fabior®Picato®Sorilux®Taclonex®          EXPERIENCE  AGENCY PARTNERSHIPS  MEDICAL COMMUNICATIONS  Agency Partners Selected & Outsourced    Medical EducationAdvertising & PromotionMarket AccessData Analytics  Execution in Progress    Payer landscapePricing & Patient assistanceContractingDistribution   years combined derm experience Derm product launches:  REIMBURSEMENT  >80    Market Conditioning& HCP Awareness  

 Acne Market Product Launch SurrogatesSignificant Rx Adoption Within 12 months of Commercialization  14  Sources: (1) Symphony Health Solutions PHAST; (2) WAC PRICES, MediSpan PriceRx®, Wolters Kluwer, 10/24/18   TRx per month  Months since launch    Average Exit TRx/Mo. = >25k Average Current WAC = $685  ~45k, $705  ~28k,$594  ~23k,$528  ~16k,$911    Valeant – Philidor Controversy   

 Rosacea Market Product Launch SurrogatesSignificant Rx Adoption Within 12 months of Commercialization  15  Sources: (1) Symphony Health Solutions PHAST; (2) WAC PRICES, MediSpan PriceRx®, Wolters Kluwer, 10/24/18   TRx per month  Months since launch  Average Exit TRx/Mo. = >25k Average Current WAC = $465  ~33k, $704  ~27k,$365  ~18k,$327     

 Nasdaq: FOMXNovember 2018           

EX-99.3

Exhibit 99.3

Foamix Announces Positive Topline Results from Phase 3 Program

Evaluating FMX103 Topical Minocycline Foam for Moderate-to-

Severe Papulopustular Rosacea

FMX103 Demonstrated Highly Statistically Significant Improvement Compared with Vehicle

in Both Co-Primary Efficacy Endpoints

Conference Call and Webcast Today at 8:30 a.m. ET

Rehovot, Israel, and Bridgewater, NJ – November 7th, 2018 – Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), (“Foamix”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced the topline results from its Phase 3 program evaluating FMX1031.5% minocycline foam, in the treatment of moderate-to-severe papulopustular rosacea. Studies FX2016-11 and FX2016-12 met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (“IGA”) treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. The safety profile of FMX103 was found to be favorable. Data from study FX2016-13 evaluating the long-term safety of FMX103 are expected to be reported in the first half of 2019.

Dr. Linda Stein Gold, a dermatologist at Henry Ford Health System, principal investigator in Study FX2016-12 and advisor to Foamix commented on the data, “These results are impressive, with treatment success being achieved in a high proportion (approximately 50%) of patients as well as clinically meaningful reductions in inflammatory lesions. Papulopustular rosacea is a serious medical condition that can cause considerable psychological distress to affected patients.  Despite the prevalence of disease, there has been limited innovation from industry. If approved, based on the compelling data from these clinical trials, I believe FMX103 could become a valuable treatment approach for rosacea.”

“We are very pleased with these top line Phase 3 results of FMX103, which demonstrate that FMX103 can provide a meaningful improvement in disease symptoms and confirm the positive results from previous clinical studies,” said David Domzalski, CEO of Foamix.  “FMX103 has the potential to address significant unmet medical needs in papulopustular rosacea.  This product leverages our proprietary foam technology, and we believe if FMX103 is approved it would be the first topical minocycline product available for rosacea patients.  We will continue to share further data from these studies as they become available over the remainder of 2018, and our goal is to file an NDA for FMX103 in the U.S. in 2019.”

“This is the second positive Phase 3 outcome for a Foamix product in the past two months, as we also achieved success in our third, confirmatory Phase 3 trial of FMX101 4% minocycline foam for the treatment of moderate-to-severe acne,” continued Mr. Domzalski. “The success of these Phase 3 trials provides further validation for our foam platform and represents the maturing of Foamix’s clinical pipeline.”

FX2016-11 and FX2016-12 Trial Design and Results

These identical, double-blind, randomized, vehicle-controlled Phase 3 studies enrolled a total of 1522 subjects, 18 years of age and older, with moderate-to-severe papulopustular rosacea at 100 sites in the United States (FX2016-11 enrollment: 751 subjects, FX2016-12 enrollment: 771 subjects).  Patients were randomized 2:1 to receive either FMX103 minocycline foam (1.5%) or vehicle foam once daily for 12 weeks, respectively.  The co-primary efficacy endpoints were: (1) the absolute change from baseline in the number of inflammatory lesions, and (2) Investigator Global Assessment (IGA) treatment success, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.  Safety and tolerability were also evaluated.

Baseline Papulopustular Rosacea Severity

In study FX2016-11, the mean inflammatory lesion count at baseline was 28.5 and 29.0 for the FMX103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (“moderate”) or 4 (“severe”) was 89.7% and 10.3%, respectively, in the FMX103 treatment group and 86.7% and 13.3%, respectively, in the vehicle treatment group.

In study FX2016-12, the mean inflammatory lesion count at baseline was 30.0 and 30.2 for the FMX103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (“moderate”) or 4 (“severe”) was 86.2% and 13.8%, respectively, in the FMX103 treatment group and 82.9% and 17.1%, respectively, in the vehicle treatment group.

Co-Primary Efficacy Assessments

The following table provides an overview of the efficacy results obtained for both co-primary endpoints for each study. In all cases, FMX103 demonstrated statistically significant improvement in subject disease severity when compared to vehicle foam.

FX2016-11 and FX2016-12 Co-Primary Endpoint Results

Study	FX2016-11			FX2016-12
Co-primary Endpoint	FMX103 N=495	Vehicle N=256	p-value	FMX103 N=514	Vehicle N=257	p-value
Absolute Change from Baseline in Inflammatory Lesion count at Week 12*	-17.57	-15.65	0.0031	-18.54	-14.88	<0.0001
IGA treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline**	52.1%	43.0%	0.027	49.1%	39.0%	0.0077

*ANCOVA, ITT, MI; **CMH test - stratified by analysis center, ITT, MI

Safety and Tolerability

The most commonly reported adverse event in both studies was upper respiratory tract infection (FX2016-11: 0.8% in the FMX103 treatment group and 2.0% in the vehicle treatment group. FX2016-12: 2.9% in the FMX103 treatment group and 3.1% in the vehicle treatment group). There were no treatment-related serious adverse events. A combined total of 9 subjects discontinued from FX2016-11 and FX2016-12 due to an adverse event (7 in the FMX103 treatment groups and 2 in the vehicle treatment groups). FMX103 appeared to be generally safe and well-tolerated. 

Conference Call and Live Webcast (with slides) @ 8.30am Eastern Time

U.S. toll free	877‑830‑2597
International	785‑424‑1743
Passcode:	TOPLINE

Webcast: http://public.viavid.com/index.php?id=132210

Replays, Available through November 21st:

US toll free:	844-512-2921
International:	412-317-6671
Replay PIN:	132210

About Papulopustular Rosacea Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.  It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life.  Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States. There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin and ivermectin), azelaic acid or retinoids, while the mainstay for the treatment of moderate-to-severe rosacea are systemic antibiotics such as minocycline and doxycycline (Drugs (2014) 74:1457-1465).

About Foamix Pharmaceuticals

Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including LEO Pharma and others.

Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the Foamix website in addition to following its press releases, filings with the Securities & Exchange Commission (“SEC”), public conference calls, and webcasts.

Forward Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions created by those sections. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays in clinical trials or announcement of results, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne, rosacea and dermatology markets, denial of reimbursement by third party payors or inability to raise additional capital, our ability to recruit and retain key employees and our ability to stay in compliance with applicable laws, rules and regulations. We discuss many of these risks in greater detail in our annual and other periodic filings with the SEC, including under the heading “Risk Factors” in our most recent annual report. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Contact:	U.S. Investor Relations
Ilan Hadar, CFO	Michael Rice
Foamix Pharmaceuticals Ltd.	LifeSci Advisors, LLC
+972-8-9316233	646-597-6979
ilan.hadar@foamix.com	mrice@lifesciadvisors.com

Media

Elizabeth Tang, PhD

LifeSci Public Relations

646-863-0222

elizabeth@lifescipublicrelations.com