<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For Quarter Ended Commission File No.
JUNE 30, 1996 0-26770
----------------- -------------------
NOVAVAX, INC.
------------------------------------------------------------
(Exact name of registrant as specified in its charter)
DELAWARE 22-2816046
------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
12111 PARKLAWN DRIVE, ROCKVILLE, MD 20852
----------------------------------- ----------
(Address of principal executive offices) (Zip code)
(301) 231-9250
-------------------------------------------------------
Registrant's telephone number, including area code
Indicate by check mark whether the Registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of theSecurities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
------ ------
The number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date:
Common Shares Outstanding at July 22, 1996
10,054,983
<PAGE> 2
NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Three months ended June 30, Six months ended June 30,
1996 1995 1996 1995
------------ ----------- ------------ -----------
<S> <C> <C> <C> <C>
Revenues:
Research revenues $ 26,997 $ - $ 26,997 $ -
Royalty revenues
from former parent - 78,943 - 132,011
------------ ----------- ------------ -----------
Cost and expenses:
Selling, general
and administrative 540,744 685,702 976,483 1,248,474
Research and development 909,912 807,384 1,735,985 1,408,411
Interest expense
to former parent - 459,320 - 880,632
Interest income (38,824) (592) (89,454) (1,006)
------------ ----------- ------------ -----------
Net loss $(1,384,835) $(1,872,871) $(2,596,017) $(3,404,500)
=========== =========== =========== ===========
Net loss per common and
common equivalent share $ (.14) $ (.19) $ (.26) $ (.34)
====== ====== ------ ======
Average number of common and
common equivalent shares 9,992,987 9,937,936 9,967,962 9,937,936
=========== =========== =========== ===========
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
1
<PAGE> 3
NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
ASSETS 1996 1995
----------- ------------
<S> <C> <C>
Current assets:
Cash and equivalents $ 3,001,841 $ 4,634,236
Receivable from former parent, net - 54,754
Prepaid expenses 56,036 72,209
----------- -----------
Total current assets 3,057,877 4,761,199
----------- -----------
Furniture and equipment - at cost 2,131,033 2,106,774
Accumulated depreciation (813,370) (705,776)
----------- -----------
1,317,663 1,400,998
----------- -----------
Patent costs, net of accumulated
amortization of $369,203 and
$323,069 in 1996 and 1995,
respectively 1,517,718 1,357,547
Deferred tax asset 100,000 -
Other assets - 9,800
----------- -----------
$ 5,993,258 $ 7,529,544
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $375,573 $391,887
Accrued payroll 19,212 38,900
Due to former parent, net 82,934 -
----------- -----------
Total current liabilities 477,719 430,787
----------- -----------
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value,
2,000,000 shares authorized - -
Common stock, $.01 par value,
30,000,000 shares authorized,
10,053,983 and 9,937,936 shares
issued and outstanding in 1996 and
1995, respectively 100,540 99,379
Additional paid in capital 30,494,438 30,188,122
Deficit(23,897,196) (21,301,179)
Deferred compensation on stock
options granted (1,182,243) (1,887,565)
----------- -----------
5,515,539 7,098,757
----------- -----------
$ 5,993,258 $ 7,529,544
=========== ===========
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
2
<PAGE> 4
NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Six months ended June 30,
1996 1995
------------- -----------
<S> <C> <C>
Cash flows from operating activities:
Net loss $(2,596,017) $(3,404,500)
Reconciliation of net loss to net cash
used by operating activities:
Non-cash compensation expense 705,322 -
Depreciation and amortization 153,728 112,894
Provision for deferred taxes (100,000) -
Changes in operating assets and liabilities:
Prepaid and other assets 25,973 (5,121)
Payable to former parent 230,474 -
Accounts payable and accrued expenses (36,002) 28,859
----------- -----------
Net cash used by operating activities (1,616,522) (3,267,868)
----------- ------------
Cash flows from investing activities:
Capital expenditures (24,259) (23,331)
Deferred patent costs (206,305) (133,831)
----------- -----------
Net cash used by investing activities (230,564) (157,162)
----------- -----------
Cash flows from financing activities:
Payable to former parent - 2,387,877
Notes payable to former parent - 1,039,109
Proceeds from exercise of common
stock options 214,691 -
----------- -----------
Net cash provided by financing activities 214,691 3,426,986
----------- -----------
Net change in cash and equivalents (1,632,395) 1,956
Cash and equivalents at beginning of year 4,634,236 16,221
----------- -----------
Cash and equivalents at June 30, 1996 and 1995 $ 3,001,841 $ 18,177
=========== ===========
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements.
3
<PAGE> 5
NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Basis of Presentation
The accompanying consolidated financial statements include the accounts of
Novavax (formerly Molecular Packaging Systems, Inc.), its wholly-owned
subsidiaries (Micro-Pak, Inc. ("Micro-Pak") and Micro Vesicular Systems, Inc.
("MVS")), and Lipovax, Inc. ("Lipovax", formerly known as Novavax, Inc.). All
significant intercompany accounts and transactions have been eliminated. These
statements have been prepared by Novavax, Inc. without audit, pursuant to the
rules and regulations of the Securities and Exchange Commission, and reflect
all adjustments which, in the opinion of management, are necessary for a fair
statement of the results for the interim periods presented. All such
adjustments are of a normal recurring nature.
The financial statements for the period January 1, 1995 through June 30,
1995 have been prepared on a combined basis from books and records maintained
by IGI, Inc. ("IGI"). These combined financial statements reflect the
financial position and results of operations of the combined companies at their
historical bases, including allocations of certain costs by IGI.
Certain information in footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
has been condensed or omitted pursuant to such rules and regulations, although
the Company believes the disclosures are adequate to make the information
presented not misleading. It is suggested that these financial statements be
read in conjunction with the financial statements and the notes thereto
included in the Company's Annual Report on Form 10-K for the year ended
December 31, 1995.
2. Net Loss Per Common Share
Net loss per share of common stock is computed by dividing net loss by the
weighted average number of shares of common stock and common stock equivalents
outstanding during the three and six month periods ended June 30, 1996.
Options granted subsequent to December 12, 1995, (the "Distribution Date") the
date on which the Company's former parent, IGI, Inc., distributed its majority
interest in Novavax to the IGI stockholders (the "Distribution") are
antidilutive and therefore have not been included in shares outstanding. The
net loss per common and common equivalent share calculated for the three and
six month periods ended June 30, 1995 is based upon weighted average shares
outstanding of 9,937,936 representing primarily shares issued in connection
with the recapitalization. These shares have been treated as outstanding as if
the transaction had occurred on January 1, 1995.
4
<PAGE> 6
NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, continued
3. Transactions with Former Parent
Charges
Through the Distribution Date, IGI charged Novavax for expenses incurred
on its behalf, including executive, legal, accounting, data processing,
consulting, cash management, human resources and employee benefits. These
costs were allocated on a variety of methods, including:
- Specific identification based on estimates of time and services provided
- Relative identification allocated based on Novavax's relationship to the
entire pool of beneficiaries
The allocation methods, while reasonable under the current circumstances,
may not represent the cost of similar activities on a separate entity basis.
Such costs of $296,786 and $593,572 have been included in general and
administrative expenses, along with interest expense of $459,320 and $880,632,
for the three and six month periods ended June 30, 1995, respectively.
Transition Services
Novavax had entered into agreements with IGI under which IGI provided
certain executive and administrative services for a period not to extend beyond
June 30, 1996. Fees for such services are based on IGI's costs. The agreement
was terminated on June 30, 1996. Costs of $85,010 and $230,474 have been
incurred for the three and six month periods ended June 30, 1996.
Revenues
Novavax earned royalties from IGI at 10% of the sales of the licensed
products. The agreements were terminated in connection with the Distribution
and execution of a license agreement with IGI (the"IGI License Agreement").
The IGI License Agreement, which was entered into as a method of transferring
the Novavax technologies was structured as a license agreement to address
various considerations of the Distribution, including tax and financing
considerations.
5
<PAGE> 7
NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, continued
4. Income Taxes
Novavax has recorded no net provision for income taxes in the accompanying
financial statements due to the existence of net operating losses. The Company
recognized a deferred tax asset in the amount of $100,000 for
alternative-minimum tax liability, which was paid in the second quarter,
related to the tax effect of the licensing agreement. For tax purposes, the
transaction was treated as income for the period ended December 31, 1995.
Novavax has recorded the license at its carryover basis because the transaction
is a transfer made among entities under common control. As all costs of
development for this technology have been expensed with the exception of the
patents retained by Novavax, the historical basis is zero.
6
<PAGE> 8
NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
The following discussion may contain "forward-looking" statements, as that
term is defined by (i) the Private Securities Litigation Reform Act of 1995
(the "Reform Act") and (ii) in releases made by the Securities and Exchange
Commission from time to time. Such statements should be read in conjunction
with the cautionary factors described in Exhibit 99 attached to the Company's
Annual Report on Form 10-K for the year ended December 31, 1995 and
incorporated into this discussion by this reference and the consolidated
financial statements and related notes. The Company's future operating results
may be affected by various trends and factors that are beyond the Company's
control. These include among other factors, changes in general economic
conditions, rapid or unexpected changes in technologies and uncertain business
conditions that affect the pharmaceutical and vaccine industries. Accordingly,
past results and trends should not be used by investors to anticipate future
results or trends.
RESULTS OF OPERATIONS
To date, Novavax has had revenues from two sources: (i) research revenues
from industry partners in consideration of either exclusive licenses or
technology applications and (ii) royalty revenues that were attributable to
product sales by IGI, Inc., the Company's former parent.
Costs and expenses for Novavax consist of the following items:
1. Selling, general and administrative expenses that include all costs
associated with the marketing of the technology to potential industry partners
and management, administrative expenses, and related costs associated with the
continuing endeavor to raise capital.
2. Research and development expenses, which include scientific staff,
facility costs, supplies and other costs related to the ongoing development of
the Novavax technologies; and
3. Interest expense that has been charged to Novavax by IGI for borrowings
and notes due to IGI through December 12, 1995.
7
<PAGE> 9
NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Three months ended June 30, 1996 compared to 1995
Revenues of $26,997, for the sale of scientific prototype vaccines and
Novasome adjuvants, were recognized during the three months ended June 30,
1996. Novavax earned royalties from IGI of 10% of licensed product sales or
$78,943 in the three months ended June 1995.
Selling, general and administrative expenses were $540,744 for the three
months ended June 1996 compared to $685,702 of expenses incurred in the three
months of 1995. Nonrecurring charges of $85,010 for transitional services in
connection with the Distribution are included in the 1996 expenses. Costs of
$296,786 included in the 1995 expenses were allocated based on Novavax being a
separate public company.
Research and development expenses were $909,912 and $807,384 for the three
months ended June 30, 1996 and 1995, respectively. The increase in these
expenses related principally to increased efforts in the development of human
pharmaceutical applications of the Novavax technologies in connection with FDA
human clinical trials.
Interest income of $38,824 was recorded in the three months ended June 30,
1996 compared with net interest expense of $458,728 related to borrowing from
IGI in the three months ended June 30, 1995.
Six months ended June 30, 1996 compared to 1995
Revenues of $26,997, for the sale of scientific prototype vaccines and
Novasome adjuvants, were recognized during the six months ended June 30, 1996.
Novavax earned royalties from IGI of 10% of licensed product sales or $132,011
in the six months ended June 30, 1995.
Selling, general and administrative expenses were $976,483 for the six
months ended June 30, 1996 compared to $1,248,474 of expenses incurred in the
first six months of 1995. Nonrecurring charges of $230,474 for transitional
services have been incurred for the six month period ended June 30, 1996.
Costs of $593,572 included in the 1995 expenses were allocated based on Novavax
being a separate public company.
Research and development expenses were $1,735,985 and $1,408,411 for the
six months ended June 30, 1996 and 1995, respectively. The increase in these
expenses related principally to increased efforts in the development of human
pharmaceutical applications of the Novavax technologies in connection with FDA
human clinical trials.
Interest income of $89,454 was recorded in the six months ended June 30,
1996 compared with net interest expense of $879,626 related to borrowing from
IGI in the six months ended June 30, 1995.
8
<PAGE> 10
NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Liquidity and Capital Resources
Novavax expects to incur substantial operating losses to conduct the time
consuming research, preclinical development and clinical trials necessary to
bring pharmaceutical products to market. These losses will continue until such
time as product sales and royalty payments generate sufficient revenue to fund
its continuing operations. In addition to funding the continuing operating
losses, the Company's rapid evolution from a research phase to a development
stage biopharmaceutical company with products in human clinical trials, has
prompted the need for expansion. The Company has signed a letter of intent to
move its operations from its present site in Rockville to more suitable leased
research, development, pilot production and administrative facilities nearby in
Columbia, MD. The move is both economically efficient and necessary from an
operational standpoint.
The Company used $1,632,395 of its cash resources during the six month
period ended June 30, 1996. In addition to revenues of $26,997, the Company
received proceeds of $214,691 from the exercise of stock options. These
proceeds enabled the Company to reduce its average monthly cash "burn rate" to
less than $275,000. The Company expects this rate to increase moderately over
the next six months. The Company's expenditures were largely related to its
human clinical product development, protection of the Company's intellectual
property, and administrative expenses.
The Company received notification that effective July 14, 1996, SmithKline
Beecham Biologicals, s.a. (SB) was terminating its Research and License
Agreement, and Option Agreement relating to one of Novavax' vaccine adjuvant
technologies. The Research and License Agreement allowed SB to utilize one of
Novavax' technologies to adjuvant certain SB vaccines. Per this contractual
agreement, the Company was to receive $125,000 of research funding during 1996.
The Company anticipates that proceeds from other sources, such as the exercise
of stock options or revenues from collaborations with industry partners, will
offset the loss of this funding.
Novavax estimates that its existing cash resources will be sufficient to
finance its operations at its current level of development activity for
approximately 12 months. During this time, Novavax will seek to obtain
additional funds through public or private equity or debt financings,
collaborative arrangements with pharmaceutical companies or from other sources.
There can be no assurance that additional funding or bank financing will be
available at all or on acceptable terms to permit successful commercialization
of Novavax or Novavax's technology and products. If adequate funds are not
available, Novavax may be required to significantly delay, reduce the scope of
or eliminate one or more of its research or development programs, or seek
alternative measures including arrangements with collaborative partners or
others that may require Novavax to relinquish rights to certain of its
technologies, product candidates or products.
9
<PAGE> 11
NOVAVAX, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
Item 1 - Legal Proceedings
There were no material developments in the litigation previously described
in the Company's Annual Report on Form 10-K for the year ended December 31,
1996.
Item 2 - Changes in Securities
The constituent instruments defining the rights of the holders of any
class of securities were not modified nor were the rights evidenced by any
class of registered securities materially limited or qualified during the
period covered by this report.
Item 3 - Defaults Upon Senior Securities
No defaults occurred during the period covered in this report.
Item 4 - Submission of Matters to a Vote of Security Holders
At the Company's Annual Meeting of Stockholders held on May 9, 1996, the
following proposals were adopted by the vote specified below:
Proposal
1. Election of Class I Directors to serve
until the 1999 meeting:
<TABLE>
<CAPTION>
For Withheld
--- --------
<S> <C> <C>
Ronald A. Schiavone 8,765,105 79,658
Ronald H. Walker 8,483,872 360,891
Wayne A. Downing 8,483,572 361,191
</TABLE>
Proposal
2. Ratification of Coopers & Lybrand L.L.P. as independent auditors of the
Company for the current fiscal year ending December 31, 1996.
<TABLE>
<CAPTION>
Number of Shares
----------------
<S> <C>
For 8,522,505
Against 306,704
Abstain 15,554
</TABLE>
Item 5 - Other information
None
10
<PAGE> 12
NOVAVAX, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION, continued
Item 6 - Exhibits and Reports on Form 8-K
(a) Exhibits:
Exhibit 11 - Computation of Net loss Per Common Share
Exhibit 27 - Financial Data Schedule
(b) Reports on Form 8-K
None
11
<PAGE> 13
NOVAVAX, INC. AND SUBSIDIARIES
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
NOVAVAX, INC.
(Registrant)
Date: July 25, 1996
By:/s/Elaine T. Bennett
------------------------
Elaine T. Bennett
Vice President
(Principal Financial
and Accounting Officer)
12
<PAGE> 1
EXHIBIT 11
NOVAVAX, INC. AND SUBSIDIARIES
COMPUTATION OF NET LOSS PER COMMON SHARE
(Unaudited)
<TABLE>
<CAPTION>
Three months ended Six months ended
June 30, June 30,
-------- --------
1996 1995 1996 1995
------- ------- ------- -------
<S> <C> <C> <C> <C>
Net loss $(1,384,835) $(1,872,871) $(2,596,017) $(3,404,500)
=========== =========== =========== ===========
Weighted average shares
outstanding based on
average market price 9,992,987 9,937,936 9,967,962 9,937,936
============ ========= =========== ===========
Net loss per
common and common
equivalent share $(.14) $(.19) $(.26) $(.34)
===== ===== ===== =====
</TABLE>
13
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1995
<PERIOD-END> JUN-30-1996
<CASH> 3,001,841
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 3,057,877
<PP&E> 2,131,033
<DEPRECIATION> (813,370)
<TOTAL-ASSETS> 5,993,258
<CURRENT-LIABILITIES> 477,719
<BONDS> 0
0
0
<COMMON> 100,540
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 5,993,258
<SALES> 26,997
<TOTAL-REVENUES> 26,997
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 2,712,468
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (89,454)
<INCOME-PRETAX> (2,596,017)
<INCOME-TAX> 0
<INCOME-CONTINUING> (2,596,017)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (2,596,017)
<EPS-PRIMARY> (.26)
<EPS-DILUTED> (.26)
</TABLE>
