UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 1997
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[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _______________ to ____________
Commission file number: 0-26642
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MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 87-0494517
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(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
320 WAKARA WAY, SALT LAKE CITY, UT 84108
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (801) 584-3600
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Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities 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 [ ]
As of April 30, 1997, the registrant had 9,199,546 shares of common stock
outstanding.
MYRIAD GENETICS, INC.
INDEX TO FORM 10-Q
Page
----
PART I - Financial Information
Item 1. Financial Statements.
Condensed Consolidated Balance Sheet as of March 31, 1997 and June 30, 1996 3
Condensed Consolidated Statements of Operations for the three months and nine months
ended March 31, 1997 and 1996 4
Condensed Consolidated Statements of Cash Flows for the three months and nine months
ended March 31, 1997 and 1996 5
Notes to Condensed Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 7
PART II - Other Information
Item 1. Legal Proceedings 11
Item 2. Changes in Securities 11
Item 3. Defaults Upon Senior Securities 11
Item 4. Submission of Matters to a Vote of Security Holders 11
Item 5. Other Information 11
Item 6. Exhibits and Reports on Form 8-K 11
SIGNATURE(S) 12
2
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
Mar. 31, 1997
(Unaudited) June 30, 1996
------------- ---------------
Assets
------
Current assets:
Cash and cash equivalents $ 16,718,418 $ 13,235,680
Marketable investment securities 19,857,579 37,212,454
Receivables 367,410 79,066
Prepaid expenses 480,203 88,423
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Total current assets 37,423,610 50,615,623
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Equipment and leasehold improvements:
Equipment 12,618,618 9,097,484
Leasehold improvements 2,003,583 863,306
Construction in progress - 810,108
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14,622,201 10,770,898
Less accumulated depreciation and amortization 2,704,025 1,375,366
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Net equipment and leasehold improvements 11,918,176 9,395,532
Long-term marketable investment securities 20,854,903 19,554,646
Other assets 50,979 41,696
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$ 70,247,668 $ 79,607,497
============= ============
Liabilities and Stockholders' Equity
------------------------------------
Current liabilities:
Accounts payable $ 1,694,231 $ 2,193,285
Accrued liabilities 826,132 786,791
Deferred revenue 5,644,498 5,661,376
Current portion of notes payable 333,922 308,658
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Total current liabilities 8,498,783 8,950,110
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Notes payable less current portion 217,943 471,640
Stockholders' equity
Common stock, $0.01 par value,15,000,000 shares authorized; issued and
outstanding 8,702,215 shares June 30, 1996, 9,059,752 shares
March 31, 1997 90,597 87,022
Additional paid-in capital 87,442,787 87,015,215
Fair value adjustment on available-for-sale marketable investment securities (42,332) (67,865)
Deferred compensation (1,509,613) (1,907,513)
Accumulated deficit (24,450,497) (14,941,112)
------------- ------------
Net stockholders' equity 61,530,942 70,185,747
------------- ------------
$ 70,247,668 $ 79,607,497
============ ============
See accompanying notes to condensed consolidated financial statements.
3
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Nine Months Ended
------------------------------ -----------------------------
Mar. 31, 1997 Mar. 31, 1996 Mar. 31, 1997 Mar. 31, 1996
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
------------- ------------- -------------- -------------
Revenues:
Research revenue $ 2,584,007 $ 1,912,080 $ 7,497,528 $ 4,593,755
Genetic testing revenue 157,678 - 191,738 -
------------- ------------- -------------- -------------
Total revenues 2,741,685 1,912,080 7,689,266 4,593,755
Expenses:
Cost of goods sold 108,696 - 132,979 -
Research and development expense 4,215,871 3,661,716 13,355,768 8,839,627
Selling, general and administrative
expense 2,393,108 933,004 6,150,175 1,826,917
------------- ------------- -------------- -------------
Total expenses 6,717,675 4,594,720 19,638,922 10,666,544
------------- ------------- -------------- -------------
Operating loss (3,975,990) (2,682,640) (11,949,656) (6,072,789)
Other income (expense):
Interest income 787,695 955,583 2,522,972 2,217,339
Interest expense (15,690) (23,444) (53,081) (75,840)
Gain/(loss) on sale of fixed assets (21,559) - (29,551) (73,436)
------------- ------------- -------------- -------------
750,446 932,139 2,440,340 2,068,063
------------- ------------- -------------- -------------
Net loss ($3,225,544) ($1,750,501) ($9,509,316) ($4,004,726)
============= ============= ============== =============
Net loss per share ($0.36) ($0.20) ($1.08) ($0.55)
============= ============= ============== =============
Weighted average shares outstanding 8,991,088 8,551,855 8,814,534 7,247,788
See accompanying notes to condensed consolidated financial statements.
4
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended Nine Months Ended
------------------------------ ------------------------------
Mar. 31, 1997 Mar. 31, 1996 Mar. 31, 1997 Mar. 31, 1996
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
------------- ------------- -------------- --------------
Cash flows from operating activities:
Net loss ($3,225,544) ($1,750,501) ($9,509,316) ($4,004,726)
Adjustments to reconcile net loss to
net cash (used in) provided by
operating activities:
Depreciation and amortization 670,310 390,737 1,779,490 1,150,380
Loss on sale of equipment 21,559 - 29,551 73,436
(Increase) decrease in receivables (243,514) 28,221 (288,344) 77,900
Increase in other assets (154,018) (79,992) (401,063) (43,760)
(Decrease) increase in accounts
payable and accrued expenses (771,720) 935,938 (459,713) 1,710,039
(Decrease) increase in deferred
revenue (55,237) 3,153,420 (16,878) 4,354,420
------------- ------------- -------------- --------------
Net cash (used in) provided
by operating activities (3,758,164) 2,677,823 (8,866,273) 3,317,689
------------- ------------- -------------- --------------
Cash flows from investing activities:
Capital expenditures (1,395,244) (2,222,548) (3,956,108) (5,414,668)
Proceeds from sale of equipment 14,750 - 22,250 36,375
Net change in marketable investment
securities 6,268,436 (2,655,786) 16,080,153 (42,289,240)
------------- ------------- -------------- --------------
Net cash provided by (used
in) investing activities 4,887,942 (4,878,334) 12,146,295 (47,667,533)
------------- ------------- -------------- --------------
Cash flows from financing activities:
Net payments of notes payable (78,148) (70,394) (228,433) (205,674)
Net proceeds from issuance of common
stock 407,062 30,369 431,149 49,125,910
Net proceeds from issuance of
preferred stock - - - 9,982,723
Conversion of preferred stock - - - (109,414)
------------- ------------- -------------- --------------
Net cash provided by (used
in) financing activities 328,914 (40,025) 202,716 58,793,545
------------- ------------- -------------- --------------
Net increase (decrease) in cash and
cash equivalents 1,458,692 (2,240,536) 3,482,738 14,443,701
Cash and cash equivalents at beginning
of period 15,259,726 28,569,973 13,235,680 11,885,736
------------- ------------- -------------- --------------
Cash and cash equivalents at end of
period $ 16,718,418 $ 26,329,437 $ 16,718,418 $ 26,329,437
============= ============= ============== ==============
See accompanying notes to condensed consolidated financial statements.
5
MYRIAD GENETICS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
(1) BASIS OF PRESENTATION
The accompanying condensed unaudited consolidated financial statements
have been prepared by Myriad Genetics, Inc. (the "Company") in
accordance with generally accepted accounting principles for interim
financial information and pursuant to the applicable rules and
regulations of the Securities and Exchange Commission. The condensed
unaudited consolidated financial statements include the accounts of
the Company and its wholly-owned subsidiaries. All material
intercompany accounts and transactions have been eliminated in
consolidation. In the opinion of management, the accompanying
financial statements contain all adjustments (consisting of normal and
recurring accruals) necessary to present fairly all financial
statements. The financial statements herein should be read in
conjunction with the Company's audited consolidated financial
statements and notes thereto for the fiscal year ended June 30, 1996,
included in the Company's Annual Report on Form 10-K for the year
ended June 30, 1996. Operating results for the three and nine month
periods ended March 31, 1997 may not necessarily be indicative of the
results to be expected for any other interim period or for the full
year.
6
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Since inception, the Company has devoted substantially all of its resources to
maintaining its research and development programs, establishing and operating a
genetic testing laboratory, and supporting collaborative research agreements.
Revenues received by the Company primarily have been payments pursuant to
collaborative research agreements. The Company has been unprofitable since its
inception and, for the quarter ended March 31, 1997, the Company had a net loss
of $3,225,544 and as of March 31, 1997 had an accumulated deficit of
$24,450,497.
In August 1995, the Company completed a three-year collaborative research and
development agreement with Eli Lilly and Company to locate and sequence the
BRCA1 breast and ovarian cancer gene. This agreement has provided the Company
with research funding and may in the future provide certain additional payments
upon the attainment of research and regulatory milestones and royalty payments
based on sales of any products resulting from the collaboration. The Company
did not recognize revenue from this agreement during the quarter ended March 31,
1997.
In April 1995, the Company commenced a five-year collaborative research and
development arrangement with Novartis Corporation ("Novartis"). This
collaboration provides the Company with an equity investment, research funding
and potential milestone payments totalling $60,000,000. The Company is entitled
to receive royalties from sales of therapeutic products sold by Novartis. The
Company recognized $1,370,494 in revenue under this agreement for the quarter
ended March 31, 1997.
In September 1995, the Company commenced a five-year collaborative research and
development arrangement with Bayer Corporation ("Bayer"). This collaboration
provides the Company with an equity investment, research funding and potential
milestone payments totalling $71,000,000. The Company is entitled to receive
royalties from sales of therapeutic products sold by Bayer. The Company
recognized $1,213,513 in revenue under this agreement for the quarter ended
March 31, 1997.
In October 1996, the Company announced the introduction of BRACAnalysis/TM/, a
comprehensive BRCA1 and BRCA2 gene sequence analysis for susceptibility to
breast and ovarian cancer. The Company, through its wholly owned subsidiary
Myriad Genetic Laboratories, Inc. ("Labs"), began accepting testing samples on a
commercial basis on October 30, 1996. Genetic testing revenues of $157,678 were
recognized for the quarter ended March 31, 1997.
In January 1997, the Company announced the identification of the first major
gene responsible for glioma, a form of brain cancer that is the leading killer
of children with cancer. In March 1997 the Company further announced that the
identified gene was also found to be associated with other advanced cancers of
the prostate, breast, kidney and skin. As a result of the additional findings,
the gene originally known as BNC1 was renamed MMAC1 (Mutated Multiple Advanced
Cancers). MMAC1 was located through a collaborative effort by scientists at the
Company and the University of Texas M.D. Anderson Cancer Center ("M.D.
Anderson"). It is anticipated that the location of MMAC1 will accelerate
development of new diagnostic and therapeutic approaches to brain, prostate,
breast, kidney, and skin cancers. There can be no assurance, however, that the
identification of this gene will lead to the development of diagnostic tests or
therapeutic products.
In February 1997, the Company announced that the U.S. Patent and Trademark
Office had granted a patent covering the AGT (Angiotensinogen) gene mutation.
The composition of matter patent on the gene mutation, which is believed to be
associated with an individual's risk for salt-dependent hypertension, was issued
to the University of Utah, and is exclusively licensed to the Company for
therapeutic applications, and co-exclusively licensed to Myriad for diagnostic
applications. There can be no assurance, however, that the patenting of this
gene will lead to the development of a diagnostic test or therapeutic products.
The Company intends to enter into additional collaborative relationships to
locate and sequence genes associated with other common diseases as well as
continuing to fund internal research projects. There can be no assurance that
the Company will be able to enter into additional collaborative relationships on
terms acceptable to the Company. The
7
Company expects to incur losses for at least the next several years, primarily
due to expansion of its research and development programs, increased staffing
costs, and expansion of its facilities. Additionally, the Company expects to
incur substantial sales, marketing and other expenses in connection with
building its genetic predisposition testing business. The Company expects that
losses will fluctuate from quarter to quarter and that such fluctuations may be
substantial.
RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 1997 AND 1996
Research revenues for the quarter ended March 31, 1997 increased $671,927 from
the same quarter of 1996. The increase was attributable to the Company's
corporate research collaboration agreements providing ongoing research funding.
Research revenue from the research collaboration agreements is recognized as
related costs are incurred. Consequently, as these programs progress and costs
increase, revenues increase proportionately.
Genetic testing revenues of $157,678 were recognized in the quarter ended March
31, 1997, an increase of $123,618 over the quarter ended December 31, 1996. The
Company anticipates genetic testing revenue to increase in the future as cancer
centers develop internal protocols for handling samples, additional insurance
companies offer reimbursement for such tests, and market awareness of such tests
is increased. There can be no assurance, however, that any of these factors
will be realized. The Company also anticipates an improved gross margin in the
future as increased sales reduce inefficiencies related to underutilization of
capacity.
Research and development expenses for the quarter ended March 31, 1997 increased
to $4,215,871 from $3,661,716 for the same quarter of 1996. This increase was
primarily due to an increase in research activities as a result of progress in
the Company's collaborations with Novartis and Bayer as well as those programs
funded by the Company, including the successful collaborative effort by the
Company and scientists at M.D. Anderson in discovering and sequencing the MMAC1
gene. The increased level of research spending includes third party research
programs, increased depreciation charges related to purchasing of additional
equipment, the hiring of additional personnel and the associated increase in use
of laboratory supplies and reagents. Such expenses will likely increase to the
extent that the Company enters into additional research agreements with third
parties.
Selling, general and administrative expenses for the quarter ended March 31,
1997 increased $1,460,104 from the same quarter of 1996. The increase was
primarily attributable to costs associated with the ongoing promotion of
BRACAnalysis/TM/ as well as additional administrative, sales, marketing and
education personnel, market research activities, educational material
development, and facilities-related costs. The Company expects its selling,
general and administrative expenses will continue to increase in support of its
genetic predisposition testing business and its research and development
efforts.
Interest income for the quarter ended March 31, 1997 decreased to $787,695 from
$955,583 for the same quarter of the prior year. This decrease was primarily
due to the decreased funds available for investment, which were expended in the
ordinary course of business, including the establishment of a genetic
predisposition testing lab and internally funded research programs. Interest
expense for the quarter ended March 31, 1997, amounting to $15,690, was due
entirely to borrowings under the Company's equipment financing facility.
RESULTS OF OPERATIONS FOR THE NINE MONTHS ENDED MARCH 31, 1997 AND 1996
Research revenues increased to $7,497,528 in the first nine months of fiscal
year 1997 from $4,593,755 in the first nine months of fiscal year 1996. The
increase was attributable to the Novartis and Bayer research collaboration
agreements providing ongoing research funding.
Genetic testing revenues of $191,738 were recognized in the nine months ended
March 31, 1997. The Company did not perform any genetic tests on a commercial
basis in the nine months ended March 31, 1996.
Research and development expenses for the nine months ended March 31, 1997
increased to $13,355,768 from $8,839,627 for the prior year. This increase was
primarily due to an increase in research activities as a result of the
8
Company's collaborations with Novartis and Bayer, and an increase in Company
funded research projects including third party research programs, increased
depreciation charges related to purchasing additional equipment, the hiring of
additional personnel and the associated increase in use of laboratory supplies
and reagents. The Company also incurred increased development expenses during
the nine month period related to the beta testing and validation of the
Company's BRACAnalysis/TM/ genetic predisposition test for mutations of the
BRCA1 and BRCA2 breast and ovarian cancer genes. Such expenses will likely
increase to the extent that the Company enters into additional research
agreements with third parties and continues to develop additional commercial
tests.
Selling, general and administrative expenses for the nine months ended March 31,
1997 increased $4,323,258 from the nine month period in the prior year. The
increase was primarily attributable to the launch and ongoing promotion of
BRACAnalysis/TM/ as well as additional administrative, sales, marketing and
education personnel, market research activities, educational material
development, and facilities-related costs. The Company expects its selling,
general and administrative expenses will continue to increase in support of its
genetic predisposition testing business and its research and development
efforts.
Interest income for the first nine months of fiscal year 1997 increased to
$2,522,972 from $2,217,339 for the first nine months of fiscal year 1996. This
increase was primarily due to the increased funds available for investment,
which were raised as a result of the Company's research and development
collaborations with Novartis and Bayer, and its initial public offering in
October 1995. Interest expense for the nine months ended March 31, 1997,
amounting to $53,081, was due entirely to borrowings under the Company's
equipment financing facility. The loss on sale of fixed assets of $29,551 in
the nine months ended March 31, 1997 and $73,436 in the nine months ended March
31, 1996 is the result of the sale of out-dated equipment.
LIQUIDITY AND CAPITAL RESOURCES
Net cash used in operating activities was $3,758,164 during the quarter ended
March 31, 1997 as compared to net cash provided by operating activities of
$2,677,823 during the same quarter of the prior year. Receivables increased
$243,514 between December 31, 1996 and March 31, 1997, primarily as a result of
trade receivables due from insurance companies and major cancer centers for
genetic predisposition testing services provided by the Company. Additionally,
the Company is due to receive reimbursement of certain legal fees which have
been incurred and paid for by the Company but which are the responsibility of
one of the Company's collaborative partners. Accounts payable decreased between
December 31, 1996 and March 31, 1997 as large equipment purchases for the
establishment of Labs were paid for by the Company during the quarter.
The Company's investing activities provided cash of $4,887,942 in the three
months ended March 31, 1997 and used cash of $4,878,334 in the three months
ended March 31, 1996. Investing activities were comprised primarily of capital
expenditures for research equipment, office furniture, and facility improvements
and marketable investment securities. During the quarter ended March 31, 1997,
the Company shifted a portion of its investment in marketable securities from
longer term investments to cash and cash equivalents in order to provide for
ongoing corporate expenditures.
Financing activities provided $328,914 during the quarter ended March 31, 1997.
The Company reduced the amount of principal owing on its equipment financing
facility by $78,148. Payments on the financing facility were offset by proceeds
of $407,062 from the exercise of options and warrants during the period.
The Company anticipates that its existing capital resources, including the net
proceeds of its initial public offering and interest earned thereon, will be
adequate to maintain its current and planned operations for at least the next
two years, although no assurance can be given that changes will not occur that
would consume available capital resources before such time. The Company's
future capital requirements will be substantial and will depend on many factors,
including progress of the Company's research and development programs, the
results and cost of clinical correlation testing of the Company's genetic tests,
the costs of filing, prosecuting and enforcing patent claims, competing
technological and market developments, payments received under collaborative
agreements, changes in collaborative research relationships, the costs
associated with potential commercialization of its gene discoveries, if any,
including the development of manufacturing, marketing and sales capabilities,
the cost and availability of third-party financing
9
for capital expenditures, and administrative and legal expenses. Because of the
Company's significant long-term capital requirements, the Company intends to
raise funds when conditions are favorable, even if it does not have an immediate
need for additional capital at such time.
CERTAIN FACTORS THAT MAY AFFECT FUTURE RESULTS OF OPERATIONS
The Company believes that this report on Form 10-Q contains certain forward-
looking statements as that term is defined in the Private Securities Litigation
Reform Act of 1995. Such statements are based on management's current
expectations and are subject to a number of factors and uncertainties which
could cause actual results to differ materially from those described in the
forward-looking statements. The Company cautions investors that there can be no
assurance that actual results or business conditions will not differ materially
from those projected or suggested in such forward-looking statements as a result
of various factors, including, but not limited to, the following: intense
competition related to the discovery of disease-related genes and the
possibility that others may discover, and the Company may not be able to gain
rights with respect to, genes important to the establishment of a successful
genetic testing business; difficulties inherent in developing genetic tests once
genes have been discovered; the Company's limited experience in operating a
genetic testing laboratory; the Company's limited marketing and sales experience
and the risk that BRACAnalysis/TM/ and any other tests which the Company
develops may not be able to be marketed at acceptable prices or receive
commercial acceptance in the markets that the Company is targeting or expects to
target; uncertainty as to whether there will exist adequate reimbursement for
the Company's services from government, private healthcare insurers and third-
party payors; and uncertainties as to the extent of future government regulation
of the Company's business. As a result, the Company's future development efforts
involve a high degree of risk. For further information, refer to the more
specific risks and uncertainties disclosed throughout this Quarterly Report on
Form 10-Q.
10
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
The Company is not a party to any litigation in any court, and management is not
aware of any contemplated proceeding by any governmental authority against the
Company.
ITEM 2. CHANGES IN SECURITIES.
During the three months ended March 31, 1997, the Company issued a total of
92,742 shares of Common Stock to various Directors, consultants, and employees
of the Company pursuant to the exercise of stock options at a weighted average
exercise price of $2.72 per share. During the same period, the Company issued a
total of 3,395 shares of Common Stock to various holders of warrants issued to
Spencer Trask Securities Incorporated and Trautman Kramer & Company, the
placement agents for the Company's 1993 private placement of Series A
Convertible Preferred Stock and 1995 private placement of Series B Convertible
Preferred Stock, respectively, at a weighted average exercise price of $15.11
per share.
No person acted as an underwriter with respect to the transactions set forth
above. In each of the foregoing instances, the Company relied on Section 4(2)
of the Securities Act of 1933, as amended (the "Securities Act") or Rule 701
promulgated under the Securities Act for the exemption from the registration
requirements of the Securities Act, since no public offerings were involved.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
ITEM 5. OTHER INFORMATION.
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits
--------
The following is a list of exhibits filed as part of this Quarterly Report on
Form 10-Q.
Exhibit
Number Description
- ------ -----------
11.1 Statement Regarding Computation of Net Loss Per Share
27.1 Financial Data Schedule
(b) Reports on Form 8-K
-------------------
No reports on Form 8-K were filed during the quarter ended March 31, 1997.
11
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.
MYRIAD GENETICS, INC.
Date: 5/12/97 By: /s/ Peter D. Meldrum
----------- ---------------------------------
Peter D. Meldrum
President and Chief Executive Officer
Date: 5/12/97 /s/ Jay M. Moyes
----------- -------------------------------------
Jay M. Moyes
Vice President of Finance
(principal financial and accounting officer)
12
MYRIAD GENETICS, INC.
EXHIBIT INDEX
Exhibit
Number Description
- ------ -----------
11.1 Statement Regarding Computation of
Net Loss Per Share
27.1 Financial Data Schedule
13