Zalicus Reports Financial Results for the Second Quarter 2013

Zalicus Reports Financial Results for the Second Quarter 2013

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the second quarter ended June 30, 2013.

"We made significant progress this quarter advancing the clinical development of our novel ion channel programs Z160, a first-in-class, oral, state dependent, selective N-type calcium channel blocker and Z944, a novel oral T-type calcium channel blocker," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "Enrollment is going well in the two Phase 2 clinical trials of Z160 for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy and postherpetic neuralgia and we remain on track to report top line data from both studies in the fourth quarter of 2013. In addition, we plan to initiate a Phase 1b study with Z944 in the third quarter of 2013."


Second Quarter 2013 and Recent Accomplishments:

  • Z944. Advancing Z944, a novel oral T-type calcium channel (Cav 3.1-3.3) blocker, into further clinical development for the treatment of pain in the third quarter of 2013. The planned Phase 1b study is a state-of-the-art experimental clinical model utilizing Laser-Evoked-Potentials (LEP) to provide an efficient and objective assessment of the activity of Z944 in an induced neuropathic pain state. Results from the LEP study can further inform Zalicus's development plans for Z944 in a variety of potential pain indications.

  • Z160. Granted a patent by the U.S. Patent and Trademark office (USPTO) covering novel formulations of Z160 and extending its patent protection and exclusivity into 2032. The patent provides broad coverage for a range of novel Z160 pharmaceutical compositions and methods of using these compositions in the treatment of pain. Z160 is a first-in-class, oral, state dependent, selective N-type calcium channel (Cav 2.2) blocker currently in two Phase 2 clinical trials for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy which began in the third quarter of 2012 and postherpetic neuralgia which began in the fourth quarter of 2012. Top line data from both studies on the same primary endpoint measuring changes in weekly mean pain score using a numerical rating scale compared to placebo are expected to be available in the fourth quarter of 2013.

  • Scientific Presentations. Presented data highlighting the benefits of Z160 and Z944 at the 32nd Annual Scientific Meeting of the American Pain Society. These data demonstrated the significant progress Zalicus has made in validating the activity of Z160 and Z944 in preclinical models of pain.

  • Publications. Published data on the benefits of utilizing the Zalicus combination High-throughput Screening (cHTS) technology for the potential treatment of ebolavirus infections. The paper, published in Science and Translational Medicine, describes work conducted by Zalicus and collaborators from the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) and the University of Virginia School of Medicine to screen and identify drugs with antifilovirus activity.

  • Ongoing Financing. Secured a new funding commitment from Lincoln Park Capital in which Zalicus has the right to sell up to $25 million in shares of its common stock at prevailing market prices at the time of sales.

Second Quarter Financial Results (Unaudited):

As of June 30, 2013, Zalicus had cash, cash equivalents, restricted cash and short-term investments of $20.8 million compared to $26.1 million as of March 31, 2013.

For the three months ended June 30, 2013, revenue was $3.9 million compared to $2.9 million for the quarter ended June 30, 2012. Zalicus recognized $1.7 million in royalty revenue from Mallinckrodt based on Exalgo® net sales for the quarter ended June 30, 2013 and Zalicus has recognized a total of $12.5 million in royalty revenue from Exalgo since its commercial launch in April 2010 through June 30, 2013.

For the quarter ended June 30, 2013, net loss was $10.6 million, or ($0.08) per share, compared to a net loss of $10.3 million, or ($0.09) per share, in the quarter ended June 30, 2012. The net loss amounts include $2.2 million and $1.0 million of non-cash Exalgo intangible amortization expense in the quarters ended June 30, 2013 and June 30, 2012, respectively. Research and development expenses were $9.8 million in the quarter ended June 30, 2013 compared to $9.9 million in the quarter ended June 30, 2012.

General and administrative expenses were $2.1 million in the quarter ended June 30, 2013 compared to $2.3 million in the quarter ended June 30, 2012.

About Zalicus

Zalicus Inc. (Nasdaq Global Market: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain such as Z160 and Z944 and has entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease. To learn more about Zalicus, please visit www.zalicus.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its product candidates, their potential, and its plans for clinical development, the Zalicus selective ion channel modulation technology, and related preclinical product candidates and intellectual property, Zalicus's combination drug discovery technology, cHTS, and its financial condition, results of operations, and other business plans. These forward-looking statements about future expectations, plans, objectives and prospects of Zalicus and its product candidates may be identified by words like "believe," "expect," "may," "will," "should," "seek," "plan," "project" or "could" and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the risks related to the formulation and clinical development of its product candidates Z160 and Z944, the unproven nature of the Zalicus ion channel drug discovery technology, risks related to the sale and marketing of Exalgo by Mallinckrodt, Zalicus's ability to obtain additional financing or funding for its research and development, and those other risks that can be found in the "Risk Factors" section of Zalicus' annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Zalicus periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Zalicus contemplated by these forward-looking statements. These forward-looking statements reflect management's current views and Zalicus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

(c) 2013 Zalicus Inc. All rights reserved.

Zalicus Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)


(Unaudited)

Three months ended June 30,

Six months ended June 30,

2013

2012

2013

2012

Revenue:

Royalties

$

1,713

$

1,250

$

3,145

$

2,368

cHTS services and other collaborations

2,178

1,674

4,420

2,876

Total revenue

3,891

2,924

7,565

5,244

Operating expenses:

Research and development

9,845

9,861

16,924

20,443

General and administrative

2,059

2,308

4,101

4,971

Amortization of intangible

2,180

973

4,361

1,946

Restructuring

28

1,129

Total operating expenses

14,084

13,170

25,386

28,489

Loss from operations

(10,193

)

(10,246

)

(17,821

)

(23,245

)

Interest income

14

44

37

85

Interest expense

(393

)

(563

)

(833

)

(1,154

)

Other income

10

8

7

Net loss before provision for income taxes

(10,562

)

(10,765

)

(18,609

)

(24,307

)

Income tax benefit

441

441

Net loss

$

(10,562

)

$

(10,324

)

$

(18,609

)

$

(23,866

)

Net loss per share—basic and diluted

$

(0.08

)

$

(0.09

)

$

(0.14

)

$

(0.22

)

Weighted average number of common shares used in net loss per share calculation—basic and diluted

130,226,594

113,730,060

128,734,247

108,760,065

Comprehensive loss

$

(10,567

)

$

(10,331

)

$

(18,620

)

$

(23,851

)

Zalicus Inc.

Condensed Consolidated Balance Sheets

(in thousands, except per share data)


(Unaudited)

June 30,
2013

December 31,
2012

Assets

Current assets:

Cash and cash equivalents

$

2,864

$

4,531

Restricted cash

50

50

Short-term investments

16,115

30,059

Accounts receivable

2,329

3,045

Prepaid expenses and other current assets

1,040

684

Total current assets

22,398

38,369

Property and equipment, net

3,016

3,535

Intangible asset, net

13,293

17,654

Restricted cash and other assets

1,803

1,817

Total assets

$

40,510

$

61,375

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

$

1,429

$

3,261

Accrued expenses and other current liabilities

5,239

4,841

Deferred revenue

3,822

4,918

Current portion of term loan payable

6,721

6,327

Current portion of lease incentive obligation

284

284

Total current liabilities

17,495

19,631

Term loan payable, net of current portion

5,310

8,772

Deferred revenue, net of current portion

600

Deferred rent, net of current portion

383

457

Lease incentive obligation, net of current portion

733

875

Other long-term liabilities

14

Stockholders' equity:

Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued and outstanding

Common stock, $0.001 par value; 200,000 shares authorized; 133,387 and 127,019 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively

133

127

Additional paid-in capital

376,089

371,912

Accumulated other comprehensive income

(1

)

10

Accumulated deficit

(359,632

)

(341,023

)

Stockholders' equity

16,589

31,026

Total liabilities and stockholders' equity

$

40,510

$

61,375



Zalicus Inc.
Justin Renz, 617-301-7575
CFO
JRenz@zalicus.com
or
Gina Nugent, 617-460-3579
gnugent@zalicus.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS:

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