Full Press Release Details
Vice President, Finance & CFO
Cerus Corporation Reports
First Quarter 2014 Results
CONCORD, CA, May 1, 2014 - Cerus Corporation (NASDAQ: CERS) today announced financial results for the first quarter
ended March 31, 2014.
The first quarter results were in-line with our expectations and reflect the impact of the strategic decisions announced
last quarter designed to improve future sales in certain markets covered by distributors. We expect that our direct sales efforts and transition to new distributors will begin to contribute to sales growth in the second half of the year. As a
result, we continue to feel comfortable with our 2014 annual revenue guidance of $38-$40 million, said William Obi Greenman, Cerus president and chief executive officer. In
addition, maturing opportunities in other regions and steady progress with the FDA review of our plasma and platelet PMA submissions remain a primary focus and give us reason to be optimistic for the remainder of the year.
Product revenue for the first quarter of 2014
was $7.9 million, a 19% decrease from the first quarter of 2013. The decrease in product revenue was driven by sales declines for both disposable kits and illuminators in several key distributor markets. This decline was expected by us and was
incorporated into our annual revenue guidance of $38-$40 million for 2014.
Gross margins on product sales for the first quarter of 2014 were 47%, compared to 48% for the first quarter of 2013. The first quarter of 2014 was our first
quarter operating under the new terms of our amended agreement with Fresenius-Kabi, the manufacturer of our disposable kits. The amended agreement is expected to provide more stability in per unit costs for our cost of goods sold than we previously
experienced. In addition, under the new terms, we expect a more efficient supply chain as Fresenius-Kabi will be sourcing and purchasing work-in-process for certain components from us.
Total operating expenses for the
first quarter of 2014 were $12.9 million, compared to $9.6 million for the first quarter of 2013. The increase in operating expenses was related to development costs incurred in connection with the support of the PMA submissions for both our
platelet and plasma products, selling, general and administrative expenses
incurred in anticipation of a potential U.S. launch of the INTERCEPT System and increased costs associated with our ongoing red blood cell clinical studies, both in Europe and the U.S. We expect
to continue making focused investments throughout 2014 as visibility into the PMA approval process and subsequent possible commercial launch for our platelet and plasma products potentially becomes more certain. We may also decide to improve the
speed of enrollment for our European red blood cell clinical trials and to accelerate the license-enabling manufacturing and development work needed to prepare for a potential CE mark regulatory submission.
Operating and Net Loss
Operating losses during the first
quarter of 2014 were $9.2 million, compared to $5.0 million for the first quarter of 2013. The lower revenues and increased operating expenses realized during the first quarter of 2014 relative to the same period in 2013 were the primary drivers for
the higher operating losses. Operating losses are expected to continue through the second quarter as we move to a direct sales model in certain regions that have historically been serviced by distributors, bring new distributors online and as we
continue to pursue potential FDA approval for the platelet and plasma products in the U.S.
Net loss for the first quarter of 2014 was $0.2 million, or
$0.12 per diluted share, compared to a net loss of $10.3 million, or $0.17 per diluted share, for the first quarter of 2013. Net losses were impacted by the mark-to-market adjustments of our outstanding warrants to fair value, which resulted in
non-cash gains of $9.0 million during the first quarter of 2014 compared to non-cash losses of $5.1 million during the comparable period in 2013.
At March 31, 2014, we had cash, cash equivalents and short-term investments of $48.3 million compared to $57.7 million at
December 31, 2013. Cash used during the first quarter is typically higher than in other quarters due to the paydown of prior year-end accruals.
Other Recent Highlights
QUARTERLY CONFERENCE CALL
The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview
and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company s web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID
number 1351152. The replay will be available approximately three hours after the call through May 14, 2014.
Cerus Corporation is a biomedical products company focused in the field of blood safety. Cerus currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Cerus is seeking regulatory approval of the INTERCEPT Blood System for plasma and
platelets. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for more information.
INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward-Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus products, prospects and
results, including statements concerning Cerus expectations regarding its 2014 revenues and future sales growth, the anticipated impact resulting from strategic changes to Cerus distributor relationships, including Cerus
expectation of sales growth resulting therefrom in the second half of 2014, Cerus expectations regarding the length of time it expects to experience increased operating losses, the potential approvals by the FDA of the modular PMAs for the
INTERCEPT Blood System for plasma and platelets, expected regulatory submissions for and FDA approval decisions related to the INTERCEPT Blood System for plasma and platelets and the timing thereof, a potential CE Mark regulatory submission for the
red blood cell system and the anticipated benefits of potential additional investments in support thereof, the potential launch in the U.S. of the INTERCEPT Blood System for plasma and platelets, future operating expenses, research and development
activity and expenses in support of Cerus regulatory submissions, the expected financial and other impacts from Cerus amended agreement with its manufacturer of disposable kits, and the future development of the INTERCEPT Blood System
for red blood cells. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer
demand for, the INTERCEPT Blood System, including the risk that the negative sales impact from the strategic changes to Cerus distributor relationships could last longer or be more severe than anticipated and that Cerus may not experience any
sales growth in the second half of 2014; the uncertain and time-consuming development and regulatory process, including the risks that Cerus may encounter unanticipated difficulties complying with the prescribed submission timing or other modular
PMA requirements related to the INTERCEPT Blood System for plasma or for platelets or that Cerus PMA submissions might not be approved by the FDA in a
timely manner or at all, and the risk that additional investments in Cerus European red blood cell clinical trials may not accelerate the timeframe in which Cerus could potentially submit a
CE mark for regulatory submission, the timing and occurrence of which remain substantially uncertain; adverse market and economic conditions, including adverse fluctuations in foreign exchange rates; Cerus reliance on third parties to market,
sell, distribute and maintain its products; Cerus ability to maintain an effective manufacturing supply chain; as well as other risks detailed in Cerus filings with the Securities and Exchange Commission, including Cerus Annual
Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 7, 2014. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
| Three Months Ended March 31, | ||||||||
| 2014 | 2013 | |||||||
| Product revenue | $ | 7,866 | $ | 9,733 | ||||
| Cost of product revenue | 4,157 | 5,090 | ||||||
| Gross profit on product revenue | 3,709 | 4,643 | ||||||
| Operating expenses: | ||||||||
| Research and development | 4,642 | 2,700 | ||||||
| Selling, general and administrative | 8,236 | 6,853 | ||||||
| Amortization of intangible assets | 50 | 50 | ||||||
| Total operating expenses | 12,928 | 9,603 | ||||||
| Loss from operations | (9,219 | ) | (4,960 | ) | ||||
| Non-operating income (expense), net | 9,032 | (5,241 | ) | |||||
| Net loss before income taxes | (187 | ) | (10,201 | ) | ||||
| Provision for income taxes | 38 | 51 | ||||||
| Net loss | $ | (225 | ) | $ | (10,252 | ) | ||
| Net loss per share: | ||||||||
| Basic | $ | (0.00 | ) | $ | (0.17 | ) | ||
| Diluted | $ | (0.12 | ) | $ | (0.17 | ) | ||
| Weighted average common shares outstanding used for computing net loss per share: | ||||||||
| Basic | 72,088 | 59,730 | ||||||
| Diluted | 75,158 | 59,730 |
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
| March 31, 2014 | December 31, 2013 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 48,255 | $ | 57,676 | ||||
| Accounts receivable, net | 4,943 | 6,125 | ||||||
| Inventories | 11,307 | 13,063 | ||||||
| Prepaid expenses and other current assets | 2,574 | 1,290 | ||||||
| Property and equipment, net | 3,166 | 2,189 | ||||||
| Goodwill and intangible assets, net | 2,610 | 2,660 | ||||||
| Other assets | 372 | 378 | ||||||
| Total assets | $ | 73,227 | $ | 83,381 | ||||
| Accounts payable and accrued liabilities | $ | 12,331 | $ | 15,487 | ||||
| Deferred revenue | 279 | 181 | ||||||
| Debt - current | 3,268 | 3,366 | ||||||
| Warrant liability | 11,356 | 20,390 | ||||||
| Other non-current liabilities | 1,126 | 1,162 | ||||||
| Total liabilities | 28,360 | 40,586 | ||||||
| Stockholders equity | 44,867 | 42,795 | ||||||
| Total liabilities and stockholders equity | $ | 73,227 | $ | 83,381 |