-Company to Commence Pilot Sales of Serenz® to European Pharmacies in 2Q 2016-
-Recently Announced CoSense® Distribution Agreements Covering the U.S. and
“At Capnia, we have achieved several important milestones over the past several months, including strengthening our CoSense sales efforts by securing two exclusive distribution agreements, one in the U.S. and one in China,” said
Fourth Quarter and Recent Highlights
CoSense and Neonatology-Focused Products
- Announced a Nationwide Distribution Agreement with
Bemes, Inc., for the Sale of CoSense in the U.S. Under the terms of the agreement, Bemes has the exclusive right to provide sales, marketing, distribution and field service activities for CoSense in the United States. Bemes and its network of sub-distributors allows comprehensive nationwide distribution of CoSense with 44 sales representatives covering almost every state.
- Announced an Exclusive Distribution Agreement with Shanghai CiiC for the Sale of CoSense in
China. CoSense sales are expected to commence by the end of 2016, subject to Shanghai CiiC securing all necessary regulatory approvals.
- Announced that the CoSense ETCO Monitor was showcased at the 2016
Mobile World Congress. CoSense was showcased by Capnia’s technology partner, Harman International, as an example of its capabilities in the health care arena. Harman has been a strategic partner to Capnia, helping Capniato develop the embedded system software and hardware aspects of CoSense.
- Announced the First Patient Enrolled in Clinical Trial for Trigeminal Neuralgia. The multi-center, placebo-controlled, single-blind, Phase 2 clinical trial is designed to enroll up to 50 patients with TN. The primary efficacy endpoint of the trial is pain relief as reported on a visual analog scale (VAS) in a subject diary, assessed through 24 hours from initial dose.
Capniaexpects to report top-line data from this trial by the end of 2016.
- Announced Receipt of Orphan Drug Designation for Nasal CO2 for the Treatment of TN. Receipt of ODD for TN provides
Capniawith seven years of market exclusivity in TN and additional financial benefits.
- Received Re-Certification of European CE Mark for Serenz for the Treatment of Allergy Symptoms. With the CE Mark, the Company plans to move forward with pilot sales of Serenz to pharmacies in the EU during the second quarter of 2016, with the intent of gathering commercial feedback on the product in preparation of a possible full launch of Serenz.
- Announced the Expiration of all Remaining Series B Warrants. The Series B warrants, which expired on
February 12, 2016, were issued as part of Capnia’s initial public offering, and had variable settlement provisions including provisions for cashless conversion.
- Closed the Second Tranche of a
$10 MillionPrivate Placement of Convertible Preferred Stock. With the closing of the $5.4 millionsecond tranche, Capniahas now completed the placement of its previously-announced $10 millionconvertible preferred stock and warrant offering with a single investor. Capniaclosed the $4.6 millionfirst tranche in October 2015.
- Joined the
Consortium for Universal Rh Disease Elimination(CURhE) as a Founding Member. CURhE is a global consortium that has been established to eradicate Hemolytic Disease of the Fetus and Newborn (HDFN), a potentially fatal disease. Capnia’s ETCO monitor is the only point-of-care device that can detect hemolysis in neonates.
Fourth Quarter 2015 Financial Results
Total revenue recognized in the three months ended
Research and development expenses in the fourth quarter of 2015 were
Sales and marketing expenses in the fourth quarter of 2015 were
General and administrative expenses in the fourth quarter of 2015 increased to
Interest expense for the three months ended
The change in fair value of warrants income for the three months ended
Net loss for the fourth quarter of 2015 was
Full Year 2015 Financial Results
Total revenue recognized for the year ended
Research and development expenses for the twelve months ended
Sales and marketing expenses for the twelve months ended
General and administrative expenses for the twelve months ended
Interest expense decreased by
Other expense for the twelve months ended
The change in fair value of warrants expense for the year ended
The inducement charge for Series C Warrants for the year ended
Net loss for the twelve months ended
Cash, cash equivalents, and marketable securities at
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, renewed focus on our therapeutic business and our ability to report data from our TN and Cluster Headache pilot trials in 2016.
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in
|Condensed Consolidated Balance Sheets|
|(in thousands, except shares and per share amounts)|
|As of December 31,||As of December 31,|
|Cash & Cash Equivalents||$||5,495||$||7,957|
|Prepaid expenses and other current assets||167||252|
|Total Current Assets||6,404||8,338|
|Property & Equipment, net||86||58|
|Other Intangible Assets, net||917||-|
|Liabilities and stockholders' equity (deficit)|
|Series B Warrant Liability||865||-|
|Line of Credit and Accrued Interest||-||102|
|Total Current Liabilities||3,193||1,290|
|Series A Warrant Liability||1,213||857|
|Series B Warrant Liability||-||17,439|
|Series C Warrant Liability||462||-|
|Total Long-Term Liabilities||1,784||18,296|
|Stockholders' equity (deficit)|
|Series A Convertible Preferred Stock, $0.001 par value,|
|40,000 shares authorized at December 31, 2015 and 2014;|
|4,555 and 0 shares issued and outstanding at|
|December 31, 2015 and December 31, 2014, respectively||1||-|
|Common stock, $0.001 par value, 100,000,000 shares|
|authorized at September 30, 2015 and December 31, 2014|
|14,017,909 and 6,769,106 shares issued and outsanding at|
|December 31, 2015 and December 31, 2014, respectively||14||7|
|Total stockholders' equity (deficit)||3,224||(11,190||)|
|Total liabilities and stockholders' equity (deficit)||$||8,201||$||8,396|
| Capnia, Inc.
| Condensed Consolidated Statements of Operations and Comprehensive Loss
| (in thousands, except shares and per share amounts)
|Three months ended||Year Ended|
|Government grant revenue||$||-||-||$||220||-|
|Cost of product revenue||257||-||353||-|
|Research and Development||1,284||608||4,536||2,242|
|Sales and Marketing||498||157||1,737||253|
|General and Administrative||1,709||1,080||6,141||2,665|
|Interest and other income (expense)|
|Change in fair value of warrant liabilities||661||(3,053||)||(516||)||(3,941||)|
|Inducement charge for Series C warrants||-||-||(3,049||)||-|
|Net loss per common share basis and diluted net loss per common share||$||(0.22||)||$||(2.05||)||$||(1.69||)||$||(10.42||)|
|Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share||13,112,612||3,516,886||9,425,880||1,270,033|
Investor Relations Contact:
Michelle Carroll/ Susie Kim Argot Partners(212) 600-1902 email@example.com firstname.lastname@example.org