Form 8-K ZS Pharma, Inc. For: Nov 10

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section�13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): November�10, 2014 (November 10, 2014)

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ZS Pharma, Inc.

(Exact name of registrant as specified in its charter)

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Delaware	�	001-36489	�	26-3305698
(State or Other Jurisdiction of Incorporation or Organization)	�	(Commission File Number)	�	(I.R.S. Employer Identification No.)

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508 Wrangler Drive, Suite 100 Coppell, Texas	�	75019
(Address of Principal Executive Offices)	�	(Zip Code)

Registrant�s telephone number, including area code: (877)�700-0240

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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:

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

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

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

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

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Item�2.02. Results of Operations and Financial Condition.

On November�10, 2014, ZS Pharma, Inc. (the �Company�) issued a press release announcing its earnings for the quarter ended September�30, 2014. A copy of the Company�s press release is attached hereto and furnished as Exhibit 99.1 and is incorporated in this report by reference.

The information in this Item�2.02 and the accompanying Exhibit 99.1 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 such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item�9.01. Financial Statements and Exhibits.

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(d)

Exhibits

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EXHIBIT NUMBER	��	DESCRIPTION
99.1	��	Press Release, dated November 10, 2014 (Third Quarter Earnings)

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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.

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	�		�	ZS PHARMA, INC.
Date: November�10, 2014	�		�	By:	�	/s/ Todd A. Creech
	�		�		�	Todd A. Creech
	�		�		�	Chief Financial Officer

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INDEX TO EXHIBITS

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EXHIBIT NUMBER	��	DESCRIPTION
99.1	��	Press Release, dated November 10, 2014 (Third Quarter Earnings)

Exhibit 99.1

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ZS Pharma Reports Third Quarter 2014 Financial Results and Provides

ZS-9 Program Update

Coppell, Texas � November�10, 2014 � ZS Pharma, Inc. (Nasdaq: ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today reported financial results for the third quarter ended September�30, 2014 and provided a program update on ZS-9 (sodium zirconium cyclosilicate), the Company�s investigational treatment for hyperkalemia.

�During the quarter, we continued to make progress on our clinical development goals, highlighted by the positive top-line results from HARMONIZE, our second Phase 3 trial of ZS-9,� said Robert Alexander, Ph.D., chief executive officer of ZS Pharma. �We were pleased with ZS-9�s ability to lower and maintain normal potassium levels and we look forward to presenting the full results at AHA on November�17^th.�

Third Quarter 2014 Financial Highlights

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As of September�30, 2014, cash and cash equivalents were $121.5 million compared with $9.2 million at December�31, 2013.

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Research and development expenses were $10.9 million for the third quarter of 2014, and $26.2 million for the nine months ended September�30, 2014, compared with $7.1 million and $17.9 million for the comparable periods in 2013. The increase in research and development expenses was primarily due to increased personnel costs and cost associated with the enrollment and completion of ZS004 (HARMONIZE), the initiation of ZS004E (HARMONIZE Extension study), the increased rate of enrollment in ZS005 (long-term safety study) during the quarter and costs related to the continuing manufacturing scale-up of ZS-9.

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General and administrative expenses were $5.7 million for the third quarter of 2014 and $14.3 million for the nine months ended September 2014, compared with $2.2 million and $3.9 million for the comparable periods in 2013. The increase in general and administrative expenses was primarily due to an increase in compensation, professional fees and other expenses to support ZS Pharma�s expanding operations, including increased spend in medical affairs and medical education programs; and the increased complexities of operating as a public company.

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Net loss was $16.9 million for the third quarter of 2014 and $43.7 million for the nine months ended September�30, 2014, compared with $9.4 million and $21.9 million for the comparable periods in 2013.

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ZS Pharma had approximately 20.8�million shares outstanding as of September�30, 2014.

Third Quarter 2014 ZS-9 Program and Corporate Highlights

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Completed enrollment in, and announced positive top-line results from HARMONIZE (ZS004), the Company�s second Phase 3 trial of ZS-9. Preliminary analyses showed that all three doses (5g, 10g, and 15g) of once daily ZS-9 met the primary endpoint, demonstrating that ZS-9 prevented recurrence of hyperkalemia when compared with placebo over a 28-day treatment period and that safety�& tolerability were generally consistent with previous studies.

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Initiated ZS004E, an extension study that will generate longer-term open-label safety and tolerability data (up to 12 months) in patients who participated in HARMONIZE. The Company currently has ZS-9 treatment data for over 6 months.

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Presented results at the Heart Failure Society of America Meeting of a secondary analysis of ZS003, the Company�s first Phase 3 trial of ZS-9. The analysis showed that once daily dosing of ZS-9 prevented the recurrence of hyperkalemia in patients with heart failure taking a stable dose of renin angiotensin aldosterone system (RAAS) inhibitor therapy.

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Presented results at the European Society of Cardiology Meeting from a pre-specified subset analysis of data from ZS003 that showed that ZS-9 facilitated the use of renin angiotensin aldosterone system (RAAS) inhibitor therapy in heart failure patients.

Upcoming Milestones

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Present results from additional analyses from ZS003, a Phase 3 trial of ZS-9, at the American Society of Nephrology Annual Meeting taking place November�11 to 16, 2014.

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Present detailed results from, HARMONIZE (ZS004), the second Phase 3 trial of ZS-9, at the American Heart Association (AHA) Scientific Meeting on Monday, November�17, 2014.

About ZS Pharma ZS Pharma is a publicly-traded, specialty pharmaceutical company based in Coppell, Texas. ZS Pharma�s lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), is an investigational treatment for hyperkalemia that is being evaluated in late-stage clinical trials to demonstrate its

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ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels. ZS Pharma is also pursuing the discovery of additional drug candidates that utilize its novel selective ion-trap technology for the treatment of kidney and liver diseases. Additional information is available at www.zspharma.com.

Forward-Looking Statements

ZS Pharma�cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as �believes,� �anticipates,� �plans,� �expects,� �indicates,� �will,� �should,� �intends,� �potential,� �suggests,� �assuming,� �designed� and similar expressions are intended to identify forward-looking statements. These statements are based on the Company�s current beliefs and expectations. These forward- looking statements include statements regarding the timing of potential regulatory submission and approval of the NDA and/or MAA for ZS-9. Inclusion of forward-looking statements should not be regarded as a representation by�ZS Pharma�that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the�ZS Pharma�business, including, without limitation: the potential for clinical data to not meet pre-specified statistical endpoints, regulatory authorities to not approve an application for ZS-9; analysis of ongoing or future potential clinical trials, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with clinical results achieved to date; the therapeutic and commercial value of ZS-9; and other risks described in�ZS Pharma�s�filings with the�Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and�ZS Pharma�undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading �Risk Factors� in�ZS Pharma�s�Quarterly Report on Form 10-Q filed with the�Securities and Exchange Commission�November 10, 2014 and its other reports, which are available from the�SEC�s�website (http://www.sec.gov) and on�ZS Pharma�s�website (http://www.zspharma.com) under the heading �Investors�. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

ZS Pharma Contacts

Adam Tomasi (Investors)	��	Denise Powell (Media)
ZS Pharma	��	Red House Consulting
650.458.4100	��	510.703.9491
[email protected]	��	[email protected]

Source: ZS Pharma

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ZS Pharma, Inc.

Condensed Statements of Operations

(Unaudited)

(In Thousands, Except for Share and per Share Amounts)

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Three�Months Ended September 30 2014

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Three�Months Ended September�30 2013

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Nine Months Ended September�30 2014

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Nine Months Ended September�30 2013

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Costs and expenses:

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Research and development

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$

10,923

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$

7,138

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$

26,158

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$

17,882

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General and administrative

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5,699

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2,224

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14,270

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3,911

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16,622

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9,362

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40,428

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21,793

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Loss from operations

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(16,622

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(9,362

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(40,428

)�

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(21,793

)�

Other (income) expense:

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Interest/other income

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(31

)�

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(5

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�

(50

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�

(25

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Interest expense

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�

272

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�

3

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�

280

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12

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Expense to mark warrants to market

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���

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�

�

32

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�

�

3,071

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�

153

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�

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�

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�

�

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Net loss

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�

(16,863

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(9,392

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(43,729

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(21,933

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Preferred stock accretion

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(173

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(310

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(515

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Net loss attributable to common shareholders

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$

(16,863

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$

(9,565

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$

(44,039

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$

(22,448

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Net loss per share attributable to common shareholders, basic and diluted

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$

(0.81

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$

(6.14

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$

(5.05

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$

(14.41

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Weighted-average common shares used to compute net loss per share attributable to common shareholders, basic and diluted

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20,818,794

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1,557,643

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8,713,664

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1,557,643

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ZS Pharma, Inc.

Condensed Balance Sheet Data

(In Thousands)

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�	��	September�30 2014		�	�	December�31 2013		�
Cash and cash equivalents	��	$	121,534	��	�	$	9,170	��
Working capital	��	$	113,314	��	�	$	4,721	��
Total assets	��	$	133,990	��	�	$	14,046	��
Accumulated deficit	��	$	(93,963	)�	�	$	(50,234	)�
Total shareholders� equity (deficit)	��	$	114,625	��	�	$	(45,182	)�

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