| Highest
Revenue Quarter and Most Patients on AB5000 Circulatory Support in
ABIOMED History
DANVERS, Mass. (November 2, 2005)—ABIOMED,
Inc. (NASDAQ: ABMD) today released financial results for the fiscal
second quarter ended on September 30, 2005. As compared to the second
quarter fiscal year 2005, revenue grew 5% to $10.9 million for the
quarter, the highest in the company's 24-year history. This quarter
the company continued the AB5000 console rental unit program and
more patients were supported with ABIOMED's AB5000 ventricular assist
device than in any previous quarter.
Recent financial and operating highlights include:
- Revenue increased 5% on a consolidated basis to $10.9 million,
and a 30% sequential growth versus fiscal first quarter 2006.
- More customers participated in the AB5000 console rental program
this quarter than last quarter. ABIOMED did not offer the rental
program in the second quarter of fiscal 2005. AB5000 consoles
increased 27% on units and 17% on revenue versus second quarter
of fiscal year 2005.
- To date, 60% of Q1 rentals converted to ownership of the consoles
and the remaining customers are still renting or working towards
an ownership agreement.
- Gross product margin for the quarter was 77% on a consolidated
basis.
- The company incurred a loss of 11 cents per share or $2.8 million
compared to a profit of 2 cents per share or approximately $0.5
million in second quarter of fiscal 2005. This was driven by planned
R&D, increased SG&A activities and the integration of
Impella.
- On a comparable basis, total disposable VADs sold were up 21%
(10% on BVS/AB5000, 102% on Impella) and exceeded 500 units.
- New publications were presented at the 17th Annual Transcatheter
Cardiovascular Therapeutics (TCT) Meeting held in October in Washington,
D.C., demonstrating both clinical success of the Impella technology
in Europe and lives saved when native hearts recover with support
on the AB5000 ventricles.
- The Centers for Medicare and Medicaid Services (CMS) updated
reimbursement guidelines for the successful recovery of the native
heart with external ventricular assist devices (VADs) became effective
October 1st, 2005. This change will provide up to a 70% increase
in reimbursement for hospitals.
- In order to continue to expand business in the U.S. and abroad,
ABIOMED has made significant strides in the hiring of top sales
talent from within the industry. ABIOMED added four new sales
representatives and two clinical specialists in the U.S. and three
sales representatives and one clinical specialist to its European
operations.
ABIOMED is currently the only company with FDA labeling on ventricular
assist devices for all potentially recoverable indications. To date,
more than 8,000 patients worldwide have been supported with these
devices. Patients who have recovered included those suffering from
cardiogenic shock resulting from myocardial infarction, myocarditis,
postpartum cardiomyopathy, ventricular septal defect, refractory
arrhythmias, failed heart transplants, right ventricular assistance
with implantable LVAD (Left VAD), and post cardiotomy cardiogenic
shock (PCCS). ABIOMED's devices encourage recovery, are easier to
implant, utilizing cannula inserted through a small incision, rather
than more traumatic bridge-to-transplant devices that core the ventricles
and always require heart lung machines for implantation. The ABIOMED
AB5000 also allows patients to walk with the support of the console,
which helps recovery.
"Although the timing of our growth has been delayed due to our
distribution challenge, we feel our opportunities remain strong,"
said Michael R. Minogue, Chairman, CEO and President of ABIOMED.
As a result of the rental program for AB5000 consoles and the timeframe
for integration and ramp up of the new sales team, ABIOMED is adjusting
the FY'06 revenue guidance from $52-56 million to the low $40 millions.
The company continues to forecast sequential quarterly growth year
over year for Q3 and Q4 FY'06. ABIOMED anticipates a loss estimate
of $14-19 million excluding $13.3 million of in-process R&D
expense, as the company continues its planned R&D investment
in new platforms and the approval path for Impella products in the
U.S.
The AbioCor and Impella technologies are medical device breakthroughs
that create new challenges in the regulatory approval process. ABIOMED
continues to work with the FDA on the AbioCor, the Impella Recover
LP 2.5 and 5.0, the Impella RD for right ventricular support, the
Minimally Invasive Cannula and other new products.
"In the past six months, ABIOMED has grown awareness of heart recovery
as the best option for patients in acute heart failure. Through
our expanding global distribution, scientific publications and growing
installed base, we are shipping more VADs per quarter than any other
company in circulatory care," continued Minogue.
Product revenues for the second fiscal quarter ended September
30, 2005 were $10.8 million or a 3.7% increase over the $10.4 million
reported for the second fiscal quarter ended September 30, 2004.
For the six month period ended September 30, 2005 revenues increased
by $1.4 million or 8% from $17.7 million in fiscal 2005 to $19.2
million in fiscal 2006.
During the quarter ended September 30, 2005 the Company had a net
loss of $2.8 million, or $0.11 per share. This compares to a net
profit of $0.5 million or $0.02 per share for the three months ended
September 30, 2004. During the six months ended September 30, 2005
the company had a net loss of $21.3 million, or $0.85 per share.
This compares to a net loss of $1.9 million or $0.09 per share for
the six months ended September 30, 2004. The loss incorporates the
year to date results of Impella, and includes a non-recurring expense
of in-process research and development of $13.3 million associated
with the acquisition of Impella.
CONFERENCE CALL AND WEBCAST INFORMATION
A conference call and webcast to discuss fiscal second quarter 2006
financial results will occur at 11:00 AM Eastern, November 2, 2005.
To participate in this call within the U.S. and Canada, dial 800-289-0493;
international callers should dial 913-981-5510. The conference ID
is 6114125. A replay of the call will be available four hours after
the call and will be available for one week. To access the replay
within the U.S. and Canada, dial 888-203-1112; international callers
should dial 719-457-0820. A webcast of the call, which will be live
and then archived for two weeks, will also be available at
www.abiomed.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”)
is a leading developer, manufacturer and marketer of medical products
designed to assist or replace the pumping function of the failing
heart. ABIOMED currently manufactures and sells the AB5000™
Circulatory Support System and the BVS® 5000 Biventricular Support
System for the temporary support of all patients with failing but
potentially recoverable hearts. In Europe, ABIOMED offers the Impella®
Recover™ minimally invasive cardiovascular support systems
under CE Mark approval. The company’s AbioCor® Implantable
Replacement Heart was the subject of an initial clinical trial under
an Investigational Device Exemption from the United States Food
and Drug Administration. The AbioCor has not been approved for commercial
distrihbution, and is not available for use or sale outside of the
initial clinical trial. For additional information please visit:
www.abiomed.com.
IMPELLA DEVICES
Impella products are investigational devices in the United States
and are not yet available for sale in the United States.
Media Contact:
Liza Heapes
ABIOMED, INC.
Media Relations
(978) 646-1668
lheapes@abiomed.com
Investor Relations Contact:
Rx Communications Group, LLC
Melody A. Carey
(917) 322-2517
mcarey@rxir.com
FORWARD-LOOKING STATEMENTS
This Release contains forward-looking statements, including statements
regarding development of ABIOMED’s existing and new products,
the Company’s progress toward commercial growth, and future
opportunities. The Company’s actual results may differ materially
from those anticipated in these forward-looking statements based
upon a number of factors, including uncertainties associated with
development, testing and related regulatory approvals, anticipated
future losses, complex manufacturing, high quality requirements,
dependence on limited sources of supply, competition, technological
change, government regulation, future capital needs and uncertainty
of additional financing and other risks and challenges detailed
in the Company’s filings with the Securities and Exchange
Commission, including the Annual Report filed on Form 10-K. Readers
are cautioned not to place undue reliance on any forward-looking
statements, which speak only as of the date of this Release. The
Company undertakes no obligation to publicly release the results
of any revisions to these forward-looking statements that may be
made to reflect events or circumstances that occur after the date
of this Release or to reflect the occurrence of unanticipated events.
###
ABIOMED, INC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands)
|
30-Sep-05 |
|
31-Mar-05 |
| ASSETS |
|
|
|
| Current Assets: |
|
|
|
| Cash and cash equivalents |
$15,264 |
|
$7,618 |
| Short-term marketable securities |
20,393 |
|
33,887 |
| Accounts receivable, net of allowance
for doubtful accounts |
|
|
|
| of
$405 at September 30, 2005 and $64 at March 31, 2005 |
7,940 |
8,635 |
| Inventories |
6,039 |
|
3,877 |
| Prepaid expenses and other current
assets |
1,385 |
|
1,207 |
| Totalcurrent assets |
51,021 |
|
55,224 |
|
|
|
|
| Long-term Investments |
|
|
2,112 |
| Property and Equipment, net of accumulated
depreciation of $11,504 |
|
|
|
| and
$10,867 at September 30, 2005 and March 31, 2005, respectively |
3,639 |
2,804 |
| Intangible assets, net |
8,790 418 |
|
418 |
| Goodwill |
18,849 |
|
|
| Other assets |
357 |
|
503 |
| Total assets |
$82,656 |
|
$61,061 |
|
|
|
|
| LIABILITIES AND STOCKHOLDERS
EQUITY |
|
|
|
| Current Liabilities: |
|
|
|
| Accounts payable |
$1,633 |
|
$1,132 |
| Accrued expenses |
4,354 |
|
3,623 |
| Deferred revenues |
228 |
|
127 |
| Total current liabilities |
6,215 |
|
4,882 |
|
|
|
|
| Commitments and Contingencies |
|
|
|
|
|
|
|
| Stockholders' Equity: |
|
|
|
| Class B Preferred Stock, $.01 par
value- Authorized- 1,000,000 |
|
|
|
| Shares;
Issued and outstanding-none |
|
|
| Common Stock, $.01 par value |
|
|
|
| Authorized
-100,000,000 shares; |
|
|
| Issued
- 26,348,129 shares at September 30, 2005 and 22,079,311 |
|
|
| shares
at March 31, 2005 |
|
|
| Outstanding
26,341,950 shares at September 30, 2005 and |
|
221 |
| 22,079,311
shares at March 31, 2005 |
263 |
|
| Additional paid-in capital |
213,664 |
|
170,095 |
| Deferred stock-based compensation |
-229 |
|
-278 |
| Accumulated deficit |
-135,146 |
|
-113,859 |
| Less treasury stock at cost; 6,179
shares at September 30, 2005 |
-66 |
|
|
| Accumulated other comprehensive loss |
-2,045 |
|
|
| Total stockholders' equity |
76,441 |
|
56,179 |
| Total liabilities and stockholders
equity |
$82,656 |
|
$61,061 |
CONSOLIDATED STATEMENTS OF OPERATION
(Unaudited)
(In Thousands except per share and share data)
|
Three Months Ended |
|
Six Months Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
| 2005 |
2004 |
2005 |
2004 |
|
|
|
|
|
|
|
|
| Revenues: |
|
|
|
|
|
|
|
| Products |
$10,758 |
|
$10,376 |
|
$19,158 |
|
$17,742 |
| Funded research and development |
178 |
|
61 |
|
201 |
|
136 |
|
10,936 |
|
10,437 |
|
19,359 |
|
17,878 |
|
|
|
|
|
|
|
|
| Costs and expenses: |
|
|
|
|
|
|
|
| Cost of product revenues |
2,448 |
|
2,429 |
|
4,781 |
|
4,186 |
| Research and development |
4,674 |
|
3,422 |
|
8,880 |
|
6,730 |
| Selling, general and administrative |
6,853 |
|
4,318 |
|
14,165 |
|
9,235 |
| Expensed in-process research and |
|
|
|
|
|
|
|
|
development |
|
|
13,306 |
|
|
13,975 |
|
10,169 |
|
41,132 |
|
20,151 |
|
|
|
|
|
|
|
|
| Income (loss) from operations |
-3,039 |
|
268 |
|
-21,773 |
|
-2,273 |
|
|
|
|
|
|
|
|
| Other income, net |
|
|
|
|
|
|
|
| Investment income |
296 |
|
177 |
|
560 |
|
341 |
| Foreign exchange gain |
-58 |
|
12 |
|
-112 |
|
4 |
| Other |
22 |
|
2 |
|
38 |
|
8 |
|
260 |
|
191 |
|
486 |
|
353 |
|
|
|
|
|
|
|
|
| Net income (loss) |
($2,779) |
|
$459 |
|
($21,287) |
|
($1,920) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net income(loss) per share: |
|
|
|
|
|
|
|
| Basic |
$ (0.11) |
|
$ 0.02 |
|
$ (0.85) |
|
$ (0.09) |
| Diluted |
$ (0.11) |
|
$ 0.02 |
|
$ (0.85) |
|
$ (0.09) |
|
|
|
|
|
|
|
|
| Weighted average shares outstanding: |
|
|
|
|
|
|
|
| Basic |
26,251,116 |
|
21,852,452 |
|
25,055,629 |
|
21,693,828 |
| diluted |
26,251,116 |
|
23,038,431 |
|
25,055,629 |
|
21,693,828 |
|