Columbia Laboratories Reports Fourth Quarter and Year-End 2012 Financial
Management will host Conference Call at 11:00 AM ET Today
LIVINGSTON, N.J. -- March 14, 2013
Columbia Laboratories, Inc. (Nasdaq: CBRX) today reported financial results
for the three- and twelve-month periods ended December 31, 2012.
Fourth Quarter Financial Highlights
*Total net revenues increased 11% to $7.1 million in the fourth quarter of
2012, compared to $6.4 million in the fourth quarter of 2011.
*Net product revenues increased 13% to $6.1 million in the fourth quarter
of 2012, compared to $5.4 million in the fourth quarter of 2011, mainly
due to higher sales of CRINONE^® 8% (progesterone gel) to Merck Serono
S.A. (“Merck Serono”).
*Operating income was $1.0 million in the fourth quarter of 2012, compared
to $1.1 million in the fourth quarter of 2011 due to a $1.2 million
increase in total operating expenses over fourth quarter 2011 levels. In
the fourth quarter of 2012, the Company recorded a $0.9 million write-off
of fixed assets relating to excess capacity at Maropack and $0.9 million
in severance charges, which were offset in part by lower personnel costs
following the 2012 workforce reduction.
*Net income for the fourth quarter of 2012 was $2.6 million, or $0.03 per
basic and $0.01 per diluted share, compared to a net loss of $1.0 million,
or $0.01 per basic and diluted share, in the fourth quarter of 2011.
*Cash, equivalents and short-term investments increased to $28.6 million at
December 31, 2012.
2012 Financial Highlights
*Total net revenues were $25.8 million in 2012, compared to $43.1 million
in 2011. The Company's 2011 revenues included $17.0 million for the
amortization of the $34 million gain on the sale of the progesterone
assets in July 2010 to Actavis Inc. (NYSE:ACT)(“Actavis”), formerly Watson
Pharmaceuticals Inc., which amortization concluded in the second quarter
of 2011, and the recognition of the $5.0 million milestone payment from
Actavis for the filing of NDA 22-139.
*Net product revenues increased 24% to $22.2 million in 2012, compared to
$18.0 million in 2011.
*Net product revenues from Merck Serono for international sales of CRINONE
8% increased 18% driven by greater sales penetration into higher priced
markets. Net product revenues from Actavis for U.S. sales of CRINONE
increased by 35% over 2011 levels due primarily to higher transfer
*Net income was $9.9 million, ($0.11 per basic and $0.03 per diluted
share), compared to net income of $20.5 million ($0.24 per basic and $0.22
per diluted share) in 2011.
*The Company turned cash-flow positive in the third quarter of 2012 and
cash-flow from operating activities was $4.3 million for the year,
compared with cash used in operations of $1.3 million in 2011.
“We are pleased to report our third consecutive quarter of profitability and
second consecutive quarter of positive operating cash flows, both significant
milestones for Columbia,” said Frank Condella, Columbia's president and chief
executive officer. “These results reflect the ongoing promotion and growth of
CRINONE by our partners, Merck Serono and Actavis, in their respective
franchises, coupled with our ongoing cost containment initiatives. We continue
to transition to a lower-cost operating model, and remain focused on
maximizing income and cash generation from our base business while we explore
potential strategic transactions.”
Fourth Quarter Financial Results
Total net revenues for the fourth quarter of 2012 were comprised of net
product revenues primarily for domestic and international sales of CRINONE to
Actavis and Merck Serono, respectively, and royalties primarily from Actavis.
Net product revenues increased by 13% to $6.1 million in the fourth quarter of
2012 as compared to $5.4 million in the fourth quarter of 2011.
*Net revenues from CRINONE sold to Merck Serono increased by $0.9 million,
or 22%, as compared to the fourth quarter of 2011, driven by greater sales
penetration into higher priced markets.
*Net revenues from product sold to Actavis decreased by $0.7 million, or
48%, as compared to the fourth quarter of 2011. Fourth quarter sales in
2011 reflected an increased level of orders by Actavis in anticipation of
potential regulatory approval for progesterone vaginal gel 8% in the
preterm birth indication. Actavis received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration (FDA) for the related NDA
(NDA 22-139) on February 24, 2012. During 2012 we continued to deliver
CRINONE to Actavis against orders placed prior to the CRL. Actavis
currently has sufficient inventory of CRINONE that we do not expect any
material orders for CRINONE during 2013. We will continue to receive
royalties on Actavis' net sales of CRINONE.
*In the fourth quarter of 2012, the Company recorded $0.5 million in net
product revenue related to the reversal of sales return reserves for
product that can no longer be returned. There was essentially no
comparable revenue in the fourth quarter of 2011.
Total royalty revenues were $0.9 million in the fourth quarters of both 2012
and 2011, primarily reflecting royalty revenues from Actavis on CRINONE
products. Columbia expects to continue to receive from Actavis royalty
revenues of 10% of U.S. net sales of certain progesterone products, including
CRINONE and the next-generation CRINONE product, for the foreseeable future.
There were essentially no other revenues in the fourth quarter of 2012 or
As a result, total net revenues for the fourth quarter of 2012 were $7.1
million, as compared to $6.4 million for the fourth quarter of 2011.
Gross profit as a percentage of total net revenues was 56% for the fourth
quarter of 2012, compared to 45% in the fourth quarter of 2011. Gross profit
as a percentage of net product revenues for the fourth quarter of 2012 was 49%
compared with 35% for the same period in 2011. The higher gross profit margin
in the 2012 quarter resulted primarily from the shift in sales mix to Merck
Serono in favor of higher-margin country markets.
General and administrative costs were $2.2 million in the fourth quarter of
2012, compared to $1.3 million in the 2011 quarter. The increase reflects
higher professional fees for business development activities and $0.9 million
in severance related to the departure of two executive officers.
In the fourth quarter of 2012, the Company recorded a $0.9 million write-off
of fixed assets relating to excess capacity at Maropack. Actavis received a
CRL from the FDA for NDA 22-139 in February 2012. During 2012 we continued to
deliver CRINONE to Actavis against orders placed prior to the CRL. Actavis
currently has sufficient inventory of CRINONE that we do not expect any
material orders for CRINONE during 2013. There was no comparable expense in
the fourth quarter of 2011.
The Company reported a research and development gain of $0.1 million in the
fourth quarter of 2012, compared to research and development costs of $0.4
million in the 2011 quarter. The 2012 quarter included lower personnel costs
following the 2012 workforce reduction and the departure in October 2012 of
Dr. Creasy, formerly vice president, clinical research, lower project
expenses, and the reimbursement by Actavis of all R&D expenses related to the
investigational preterm birth indication.
As a result, total operating expenses were $3.0 million in the fourth quarter
of 2012, compared to $1.8 million in the prior year period.
Operating income in the fourth quarter of 2012 was $1.0 million, compared to
operating income of $1.1 million in the prior year period. The change
primarily reflects the $0.7 million increase in net product revenues and a
$0.4 million reduction in cost of revenues, offset by the $1.2 million
increase in operating expenses, in the fourth quarter of 2012.
Other income and expense aggregated to a net income of $1.7 million for the
fourth quarter of 2012, compared to a net expense of $2.1 million in the
fourth quarter of 2011, primarily reflecting the recognition of the $1.6
million change in the fair value of the warrants issued in conjunction with
the October 2009 stock issuance resulting from the decrease in Columbia's
stock price from September 30, 2012 to December 31, 2012. In the corresponding
quarter ended December 31, 2011, the increase in Columbia's stock price from
September 30, 2011, to December 31, 2011, resulted in the recognition of a
$2.2 million unrealized loss on the fair value of stock warrants.
As a result, the Company reported net income of $2.6 million, or $0.03 per
basic and $0.01 per diluted share, for the fourth quarter of 2012, compared to
a net loss of $1.0 million, or ($0.01) per basic and diluted share, for the
fourth quarter of 2011.
Full Year Financial Results
Total net revenues for the year ended December 31, 2012, were $25.8 million,
compared to total net revenues of $43.1 million for the year ended December
31, 2011. The 40% decrease in total net revenues was due to the recognition in
2011 of $17.0 million in revenue related to the gain on the sale of the
progesterone assets to Actavis and the $5.0 million milestone payment from
Actavis for the filing of NDA 22-139, which more than offset the growth in net
product revenues in 2012.
Net product revenues for 2012 increased 24% to $22.2 million, as compared with
$18.0 million for 2011. Underlying factors include a $1.1 million, or 35%,
increase in net product revenues from Actavis and a $2.6 million, or 18%
increase in net product revenues from Merck Serono for international sales of
CRINONE 8%, slightly offset by the absence of STRIANT net product revenues in
2012 as a result of the sale of STRIANT to Actient in April 2011.
Total royalty revenues increased 16% to $3.5 million in 2012 as compared to
$3.0 million in 2011.
Total other revenues were $0.1 million in 2012. This compares to $22.1 million
in 2011, which period included the recognition of $17.0 million of the
amortization of the $34 million in deferred gains from the sale of
progesterone products to Actavis and the $5.0 million milestone payment from
Actavis for the filing of NDA 22-139.
Gross profit as a percentage of total net revenues was 50% in 2012, compared
to 73% in 2011. Gross profit as a percentage of total net revenues for 2011
would have been 44% excluding the deferred gain recognition and the NDA filing
milestone. Gross profit as a percentage of net product revenues for 2012 was
42% compared with 35% for 2011.
Total operating expenses were $10.2 million in 2012, compared to $8.4 million
in the prior year.
*There were no selling and distribution expenses in 2012. Selling and
distribution expenses were $0.1 million in 2011, in support of sales of
STRIANT prior to its sale to Actient.
*General and administration expenses increased 6% to $8.6 million in 2012,
compared to $8.1 million in 2011, due to severance costs of approximately
$1.4 million which were recorded in 2012. Excluding these one-time costs,
general and administrative costs would have decreased by $0.9 million or
*Research and development costs decreased 72% to $0.8 million in 2012 as
compared to $2.8 million in 2011, as a result of the workforce reduction
in the first quarter of 2012 and the departure of the Company's vice
president, clinical research, in October 2012.
*In 2012, the Company recorded a $0.9 million write-off of fixed assets
relating to excess capacity at Maropack as previously described. There was
no comparable expense in 2011.
*In 2011 the Company recorded a $2.5 million net gain on the sale of
STRIANT. There was no similar gain in 2012. Excluding this gain, total
operating expenses were $11.0 million in 2011.
Operating income was $2.8 million in 2012 compared to $22.9 million in 2011.
The change primarily reflects the absence of $22.0 million in non-recurring
other revenues and $2.5 million net gain on the sale of STRIANT in 2011, which
more than offset the $4.2 million increase in net product revenues and $0.5
million increase in royalty revenues in fiscal 2012.
Other income and expense aggregated to net income of $7.1 million in 2012
compared toa net expense of $2.4 million in 2011, primarily reflecting the
recognition of the $7.0 million unrealized gain on the fair value of the stock
warrants issued in conjunction with the October 2009 stock issuance resulting
from the decrease in Columbia's stock price from December 31, 2011 to December
As a result, the Company reported net income for 2012 of $9.9 million, or
$0.11 per basic and $0.03 per diluted share, compared to net income of $20.5
million, or $0.24 per basic and $0.22 per diluted share, for 2011.
Cash and Equivalents
At December 31, 2012, Columbia had cash, cash equivalents and short-term
investments of $28.6 million, compared to cash, cash equivalents and
short-term investments of $25.6 million at September 30, 2012, and $25.1
million at December 31, 2011.
Subsequent Material Events
Management Team Changes
On January 15, 2013, the Company entered into an employment agreement with
Jonathan B. Lloyd Jones, ACA, MBA, as Vice President, Finance, Chief Financial
Officer, Treasurer and Secretary, effective January 21, 2013, and terminated
without cause, effective January 31, 2013, the employment agreements of
Lawrence Gyenes as Senior Vice President, Chief Financial Officer, and
Treasurer, and Michael McGrane as Senior Vice President, General Counsel, and
Secretary of the Company.
On January 16, 2013, the Company announced plans to relocate its corporate
headquarters from Livingston, New Jersey, to Boston, Massachusetts.
Columbia has streamlined the organization to operate as cash flow
neutral-to-positive and expects to further reduce overall operating costs
through its upcoming relocation. The Company continues to evaluate potential
strategic transactions to add value for its stockholders. Any significant
expenses resulting from the relocation or pursuit of a possible strategic
transaction could affect cash flow in the quarters incurred.
As previously announced, Columbia Laboratories will hold a conference call to
discuss financial results for the fourth quarter and year ended December 31,
2012, as follows:
Date: Thursday March 14, 2013
Time: 11:00 am ET
Dial-in numbers: (877) 303-9483 (U.S. & Canada) or (760) 666-3584
Live webcast: www.columbialabs.com, under 'Investor'
The teleconference replay will be available two hours after completion through
Thursday, March 21, 2013, at (855) 859-2056 (U.S. & Canada) or (404) 537-3406.
The conference ID for the replay is 11511952. The archived webcast will be
available for one year on the Company's website, www.columbialabs.com, in the
'Investor' section under 'Events'.
About Columbia Laboratories
Columbia Laboratories, Inc. is a publicly traded specialty pharmaceutical
company with a successful history of developing proprietary, vaginally
administered products for women’s health indications. The Company receives
sales and royalty revenues from CRINONE^® 8% (progesterone gel), which is
marketed by Actavis, Inc., in the United States and by Merck Serono S.A. in
over 60 foreign countries.
Columbia's press releases and other company information are available online
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995: This communication contains forward-looking statements, which statements
are indicated by the words “may,” “will,” “plans,” “believes,” “expects,”
“anticipates,” “potential,” “should,” and similar expressions. Such
forward-looking statements involve known and unknown risks, uncertainties, and
other factors that may cause actual results to differ materially from those
projected in the forward-looking statements. Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak only as
of the date on which they are made. Factors that might cause future results to
differ include, but are not limited to, the following: Actavis' and Merck
Serono's success in marketing CRINONE for use in infertility in their
respective markets; successful development by Actavis of a next-generation
vaginal progesterone product for the U.S. market; difficulties or delays in
manufacturing; the availability and pricing of third-party sourced products
and materials; successful compliance with FDA and other governmental
regulations applicable to manufacturing facilities, products and/or
businesses; changes in the laws and regulations; the ability to obtain and
enforce patents and other intellectual property rights; the impact of patent
expiration; the impact of competitive products and pricing; the cost of
evaluating potential strategic transactions; the cost of the Company's pending
relocation to Boston; Columbia’s ability to timely regain compliance with the
Nasdaq minimum closing bid price rule; the strength of the United States
dollar relative to international currencies, particularly the euro;
competitive economic and regulatory factors in the pharmaceutical and
healthcare industry; general economic conditions; and other risks and
uncertainties that may be detailed, from time-to-time, in Columbia's reports
filed with the SEC, including, but not limited to, its Quarterly Report on
Form 10-Q for the period ended September 30, 2012. Columbia does not undertake
any responsibility to revise or update any forward-looking statements
contained herein, except as expressly required by law.
CRINONE^® is a registered trademark of Actavis, Inc.
STRIANT^® is a registered trademark of Actient Pharmaceuticals LLC
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Twelve Months Ended December 31 Three Months Ended December 31
2012 2011 2012 2011
Net product $ 22,230,473 $ 17,977,608 $ 6,129,123 $ 5,441,467
Royalties 3,459,852 2,970,980 927,655 900,754
Other revenues 138,052 22,113,433 34,484 34,648
Total net $ 25,828,377 $ 43,062,021 $ 7,091,262 $ 6,376,869
COST OF 12,788,264 11,691,365 3,132,640 3,530,155
Gross profit 13,040,113 31,370,656 3,958,622 2,846,714
Selling and — 87,669 — —
General and 8,570,094 8,108,194 2,193,533 1,342,774
Research and 770,642 2,779,058 (85,903 ) 416,624
impaired 889,869 — 889,869 —
Net gain on
U.S. sale of — (2,533,127 ) — —
operating 10,230,605 8,441,794 2,997,499 1,759,398
Income from 2,809,508 22,928,862 961,123 1,087,316
Interest 238,033 107,257 56,949 70,862
Interest — (12,111 ) — (448 )
Change in fair
value of — (2,721,205 ) — —
gain (loss) on 6,995,099 556,662 1,595,530 (2,233,675 )
Other, net (122,660 ) (292,991 ) 15,428 60,160
income 7,110,472 (2,362,388 ) 1,667,907 (2,103,101 )
Income (loss) 9,919,980 20,566,474 2,629,030 (1,015,785 )
State income (2,707 ) (8,282 ) 2,311 29,428
Federal income — (31,000 ) — (31,000 )
Net income $ 9,917,273 $ 20,527,192 $ 2,631,341 $ (1,017,357 )
BASIC $ 0.11 $ 0.24 $ 0.03 $ (0.01)
DILUTED $ 0.03 $ 0.22 $ 0.01 $ (0.01)
BASIC 87,315,808 86,325,350 87,330,865 87,296,140
DILUTED 88,504,274 92,549,153 88,552,999 87,296,140
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS 2012 2011
Cash and cash equivalents $ 13,204,067 $ 10,114,163
Short term investments 15,433,967 15,023,999
Accounts receivable, net 3,422,653 4,695,410
Inventories 2,626,606 3,635,730
Prepaid expenses and other current assets 1,284,279 667,927
Total current assets 35,971,572 34,137,229
Property and equipment, net 927,227 1,481,071
Other assets 38,882 464,286
TOTAL ASSETS $ 36,937,681 $ 36,082,586
Accounts payable 1,504,677 3,526,171
Accrued expenses 2,216,524 3,016,596
Deferred revenues 93,750 93,750
Total current liabilities 3,814,951 6,636,517
Deferred revenue 33,526 46,416
Common stock warrant liability 1,173,747 8,168,846
TOTAL LIABILITIES 5,022,224 14,851,779
COMMITMENTS AND CONTINGENCIES
Contingently redeemable series C preferred
stock 550 and 600 shares issued and
outstanding in 2012 and 2011, respectively 550,000 600,000
(liquidation preference of $550,000 and
$600,000 in 2012 and 2011, respectively)
Preferred stock, $.01 par value; 1,000,000
shares authorized, Series B convertible
preferred stock, 130 shares issued and 1 1
outstanding (liquidation preference of
Series E convertible preferred stock, 22,740
shares issued and outstanding (liquidation 227 227
preference of $2,274,000)
Common Stock $.01 par value; 150,000,000
shares authorized; 87,543,781 and 87,367,313 875,437 873,673
shares issued in 2012 and 2011, respectively
Capital in excess of par value 278,697,432 278,060,138
Less cost of 36,448 treasury shares (125,381 ) (125,381 )
Accumulated deficit (248,365,480 ) (258,282,753 )
Accumulated other comprehensive income 283,221 104,902
TOTAL SHAREHOLDERS' EQUITY 31,365,457 20,630,807
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 36,937,681 $ 36,082,586
Columbia Laboratories, Inc.
Jonathan Lloyd Jones, 973-486-8818
Vice President & CFO
The Trout Group LLC
Seth Lewis, 646-378-2952
Senior Vice President
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