Company Initiates Phase 2 ALTU-238 Clinical Trial in Pediatric
Subjects
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) today reported financial
results for the quarter and year ended December 31, 2008.
Fourth Quarter Results
For the fourth quarter of 2008, the Company reported a net loss
attributable to common stockholders of $24.8 million, or $0.80 per basic
share, compared to net income attributable to common stockholders of
$5.4 million, or $0.18 per basic share, in the fourth quarter of 2007.
Altus reported negative revenue of $0.5 million in the fourth quarter of
2008 compared to revenue of $26.8 million in the fourth quarter of 2007.
The fourth quarter 2007 revenue included $25.1 million associated with
our former ALTU-238 collaboration agreement with Genentech, which was
terminated effective December 31, 2007.
Research and development expenses totaled $22.3 million in the fourth
quarter of 2008 compared to $21.1 million in the fourth quarter of 2007.
The increase in research and development expenses is primarily due to an
increase in costs relating to the TrizytekTM program.
General, sales and administrative expenses were $3.0 million in the
fourth quarter of 2008 compared to $5.0 million in the fourth quarter of
2007.
Full Year Results
The Company reported a net loss attributable to common stockholders of
$96.8 million, or $3.13 per share, for the full year ended December 31,
2008, compared to a net loss attributable to common stockholders of
$63.5 million, or $2.23 per share, for the full year ended December 31,
2007. Total revenue was $2.2 million for 2008 compared to $28.5 million
in 2007. The 2007 revenue reflects the termination of our ALTU-238
collaboration agreement with Genentech.
Research and development expenses totaled $83.6 million for 2008
compared to $70.6 million in 2007. Research and development expense for
2008 increased primarily due to increases in manufacturing and clinical
costs relating to the Trizytek program. General, sales and
administrative expenses were $17.8 million in 2008 compared to $18.2
million in 2007.
The Company's cash, cash equivalents and marketable securities balance
at December 31, 2008 was $48.6 million. Altus believes the current cash,
cash equivalents and marketable securities position will last into the
fourth quarter of 2009. During the next three to six months, the Company
will pursue raising additional capital.
On March 11, 2009, the Company filed with the SEC its Annual Report on
Form 10-K, which included an audit opinion with a "going concern"
explanatory paragraph. The going-concern explanatory paragraph from
Altus' independent registered public accounting firm expressed
substantial doubt, based upon current financial resources, as to whether
Altus can continue to meet its obligations beyond 2009 without access to
additional working capital.
2009 Financial Guidance
Based on our current operating plans, including the expected timing and
cost of the ALTU-238 Phase 2 pediatric trial, Altus expects its net cash
used in operating activities to be between $50 million and $60 million
in 2009.
On January 26, 2009, Altus announced a strategic realignment of product
development priorities to focus on the advancement of the Company's
long-acting, recombinant human growth hormone candidate, ALTU-238, as a
once-per-week treatment for adult and pediatric patients with growth
hormone deficiency. To conserve capital resources, Altus is
discontinuing its Trizytek program activities. This discontinuation
resulted in the transfer of certain Trizytek intellectual property
rights and regulatory filings to Cystic Fibrosis Foundation
Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic
Fibrosis Foundation, in accordance with Altus' 2001 strategic alliance
agreement with CFFT. On February 20, 2009, Altus and CFFT entered into a
letter agreement and a license agreement terminating the 2001 strategic
alliance agreement. Under the terms of the license agreement, Altus
assigned the Trizytek trademark and certain patent rights to CFFT and
granted CFFT an exclusive, worldwide, royalty-bearing license to use
certain other intellectual property owned or controlled by Altus to
develop, manufacture and commercialize any product using, in any
combination, the three active pharmaceutical ingredients which comprise
Trizytek. In these agreements, Altus also agreed to assist CFFT with a
transition of on-going development and regulatory activities and
clinical trials relating to Trizytek through March 27, 2009, after which
CFFT will be responsible for future development activities. In exchange,
CFFT agreed to release Altus from all obligations and liabilities
resulting from the strategic alliance agreement, and to pay Altus a
percentage of any proceeds CFFT realizes associated with respect to any
rights licensed or assigned to CFFT under the license agreement.
As a result of this strategic realignment, Altus is implementing a
workforce reduction of approximately 75%, primarily in functions related
to the Trizytek program as well as certain general and administrative
positions. Following the staff reduction, which is expected to be
completed in the first quarter of 2009, Altus will have approximately 35
employees at its headquarters in Waltham, MA.
"We believe that ALTU-238 represents a promising opportunity to make a
major impact on the multi-billion dollar market for growth hormone
replacement products. As a mid-stage program with a relatively
straight-forward path toward regulatory approval, narrowing our focus on
ALTU-238 will enable Altus to preserve capital, minimize clinical and
regulatory risk, and build value for our shareholders," stated Dr.
Georges Gemayel, President and Chief Executive Officer of Altus
Pharmaceuticals.
ALTU-238 Program Update
ALTU-238 is being developed as a subcutaneously administered, long
acting formulation of recombinant human growth hormone (hGH) that
employs Altus' proprietary protein crystallization and formulation
technology, for patients with growth hormone deficiencies. Unlike
current hGH therapies that are administered daily, ALTU-238 is being
developed and tested to provide a once-per-week dosage formulation that
can be administered through a fine gauge needle. Altus has successfully
completed a Phase 2 trial with ALTU-238 in adult subjects and recently
completed a Phase 1c trial confirming the safety, pharmacokinetic and
pharmacodynamic (PK/PD) profile of a single dose of ALTU-238 compared to
seven daily injections of Nutropin AQ.
Dr. Gemayel concluded, "I am pleased to announce that we have initiated
the Phase 2 trial for ALTU-238 in growth hormone deficient pediatric
subjects. We will begin to screen patients shortly and we anticipate
that the first subject will be dosed within the next several weeks. We
expect to report 6 month primary efficacy data in the second quarter of
2010."
Conference Call Access Information
The Company will host a conference call to discuss the results at 11:00
a.m. ET on March 11. The call may be joined via telephone by dialing
(877) 718-5104 or (719) 325-4749 (for international participants) at
least 5 minutes prior to the start of the call. The conference
confirmation code is: 6842696. For 72 hours following the call, an audio
replay can be accessed by dialing (719) 457-0820 or (888) 203-1112 and
using the conference confirmation code 6842696. A live audio webcast of
the call will also be available on the "Investor Relations" section of
the Company's website, www.altus.com.
An archived audio webcast will be available on the Altus website
approximately two hours after the event and will be archived for 30 days.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of oral and injectable protein
therapeutics. The Company's website is www.altus.com.
Safe Harbor Statement
Certain statements in this news release concerning Altus' business are
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, those relating to the anticipated net
cash requirements to be used to fund on-going development programs and
operations in 2009, the amount of time that the Company's existing cash
resources will be available to fund operating expenses, the amount of
cash the Company expects to use in operating activities in 2009, the
ability of the Company to raise additional capital in order to enable it
to continue as a going concern, the expected market for ALTU-238, the
timing for patient enrollment in the Phase 2 clinical trial for
ALTU-238, the times at which the Company expects to be able to report
clinical trial data and results for the ALTU-238 pediatric Phase 2
trial, and the future of the ALTU-238 program. Any or all of the
forward-looking statements in this press release may turn out to be
wrong. They can be affected by inaccurate assumptions Altus might make
or by known or unknown risks and uncertainties, including, but not
limited to uncertainties as to the ability to obtain additional funding
needed for further research and development of ALTU-238, the success in
implementing the strategic realignment, including realizing anticipated
cost reductions, the future cost, timing, enrollment and success of
ongoing and planned clinical trials; the risk of demonstrating the
ultimate potential of ALTU-238; the continuing risks associated with the
development and manufacture of products to supply the clinical trials
and the unproven safety and efficacy of ALTU-238. Consequently, no
forward-looking statement can be guaranteed, and actual results may vary
materially. Additional information concerning factors that could cause
actual results to materially differ from those in the forward-looking
statements is contained in Altus' reports to the Securities and Exchange
Commission, including in Item 1A "Risk Factors" and elsewhere in its
Annual Report on Form 10-K for the year ended December 31, 2008.
However, Altus undertakes no obligation to publicly update
forward-looking statements, whether because of new information, future
events or otherwise.
| ALTUS PHARMACEUTICALS INC. (ALTU) |
|
|
|
|
|
|
|
|
| Condensed Consolidated Statements of Operations |
| |
| |
| |
| (Unaudited, in thousands, except per share amounts) |
|
|
|
|
|
|
|
| | | | | | | |
| | Three Months Ended | | Year Ended |
| | December 31, | | December 31, |
| | | | | | | |
|
| | | 2008 | | | | 2007 | | | | 2008 | | | | 2007 | |
| | | | | | | |
|
|
Contract revenue
| |
$
|
(461
|
)
| |
$
|
26,771
|
| |
$
|
2,161
|
| |
$
|
28,487
|
|
| | | | | | | |
|
|
Costs and expenses, net:
| | | | | | | | |
|
Research and development
| | |
22,327
| | | |
21,111
| | | |
83,555
| | | |
70,569
| |
|
General, sales and administrative
| | |
2,993
| | | |
5,015
| | | |
17,782
| | | |
18,172
| |
Reacquisition of European Marketing Rights from
| | | | | | | | |
|
Dr. Falk Pharma GmbH
| | |
-
| | | |
-
| | | |
-
| | | |
11,493
| |
|
Gain on termination of Genentech, Inc.
| | | | | | | | |
|
collaboration and license agreement
| |
|
-
|
| |
|
(4,000
|
)
| |
|
-
|
| |
|
(4,000
|
)
|
| | | | | | | |
|
|
Total costs and expenses —net
| |
|
25,320
|
| |
|
22,126
|
| |
|
101,337
|
| |
|
96,234
|
|
| | | | | | | |
|
|
Income (loss) from operations
| |
|
(25,781
|
)
| |
|
4,645
|
| |
|
(99,176
|
)
| |
|
(67,747
|
)
|
| | | | | | | |
|
|
Other income (expense):
| | | | | | | | |
|
Interest income
| | |
259
| | | |
1,600
| | | |
2,921
| | | |
6,683
| |
|
Interest expense and other
| | |
826
| | | |
(374
|
)
| | |
(215
|
)
| | |
(1,185
|
)
|
|
Foreign currency exchange loss
| |
|
(36
|
)
| |
|
(405
|
)
| |
|
(152
|
)
| |
|
(983
|
)
|
| | | | | | | |
|
|
Total other income (expense) —net
| |
|
1,049
|
| |
|
821
|
| |
|
2,554
|
| |
|
4,515
|
|
| | | | | | | |
|
|
Net income (loss)
| | |
(24,732
|
)
| | |
5,466
| | | |
(96,622
|
)
| | |
(63,232
|
)
|
| | | | | | | |
|
|
Preferred stock dividends and accretion
| |
|
(57
|
)
| |
|
(57
|
)
| |
|
(225
|
)
| |
|
(225
|
)
|
| | | | | | | |
|
|
Net income (loss) attributable to common stockholders
| |
$
|
(24,789
|
)
| |
$
|
5,409
|
| |
$
|
(96,847
|
)
| |
$
|
(63,457
|
)
|
| | | | | | | |
|
|
Net income (loss) attributable to common
| | | | | | | | |
|
stockholders per share - basic
| |
$
|
0.80
|
| |
$
|
0.18
|
| |
$
|
(3.13
|
)
| |
$
|
(2.23
|
)
|
| | | | | | | |
|
|
Weighted average shares outstanding - basic
| |
|
31,131
|
| |
|
30,741
|
| |
|
30,960
|
| |
|
28,459
|
|
| | | | | | | |
|
|
Net income (loss) attributable to common
| | | | | | | | |
|
stockholders per share - diluted
| |
$
|
0.80
|
| |
$
|
0.16
|
| |
$
|
(3.13
|
)
| |
$
|
(2.23
|
)
|
| | | | | | | |
|
|
Weighted average shares outstanding - diluted
| |
|
31,131
|
| |
|
32,939
|
| |
|
30,960
|
| |
|
28,459
|
|
| | | | | | | |
|
| | | | | | | |
|
|
|
|
|
|
| | | | |
| Condensed Consolidated Balance Sheets | | | | | | | | |
| (Unaudited, in thousands) |
|
|
|
| | | | |
| | | | | | | |
|
| | December 31, | | December 31, | | | | |
| |
| 2008 |
| |
| 2007 |
| | | | |
| | | | | | | |
|
|
Cash, cash equivalents and marketable securities
| |
$
|
48,600
| | |
$
|
138,332
| | | | | |
|
Accounts receivable
| | |
-
| | | |
3,454
| | | | | |
|
Prepaid expenses and other current assets
| | |
2,350
| | | |
2,001
| | | | | |
|
Property and equipment, net
| | |
9,601
| | | |
5,991
| | | | | |
|
Other assets, net
| |
|
3,700
|
| |
|
4,332
|
| | | | |
|
Total assets
| |
$
|
64,251
|
| |
$
|
154,110
|
| | | | |
| | | | | | | |
|
|
Current liabilities
| |
$
|
16,521
| | |
$
|
19,616
| | | | | |
|
Noncurrent liabilities
| | |
11,126
| | | |
8,302
| | | | | |
|
Redeemable preferred stock
| | |
6,731
| | | |
6,506
| | | | | |
|
Total stockholders' equity
| |
|
29,873
|
| |
|
119,686
|
| | | | |
|
Total liabilities, redeemable preferred stock and
| | | | | | | | |
|
stockholders' equity
| |
$
|
64,251
|
| |
$
|
154,110
|
| | | | |
Altus Pharmaceuticals Inc.
John A. Jordan, 781-373-6452
Senior
Director, Corporate Communications