<PAGE>
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): July 21, 1997
CONCEPTUS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware 0-27596 94-3170244
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
1021 Howard Avenue
San Carlos, CA 94070
(Address of Principal Executive Offices and Zip Code)
(415) 802-7240
(Registrant's Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
<PAGE>
ITEM 5. OTHER EVENTS
On July 21, 1997, Conceptus, Inc., a Delaware corporation (the "Company"),
announced the commencement of international sales of its ERA (Endometrial
Resection and Ablation) Resectoscope Sheath. Further details regarding this
announcement are contained in the Company's press release dated July 21, 1997
attached as an exhibit hereto and incorporated by reference herein.
On July 24, 1997, the Company announced its financial results for the
second quarter ended June 30, 1997. Further details regarding this
announcement are contained in the Company's press release dated July 24, 1997
attached as an exhibit hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
Exhibit 99.1 Conceptus, Inc. Press Release dated July 21, 1997.
Exhibit 99.2 Conceptus, Inc. Press Release dated July 24, 1997.
<PAGE>
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.
CONCEPTUS, INC.
Date: July 24, 1997 By:
-------------------------------------------
Sanford Fitch
Senior Vice President and Chief
Financial Officer
<PAGE>
CONCEPTUS, INC.
INDEX TO EXHIBITS
Exhibit
Number
- -------
99.1 Press Release dated July 21, 1997
99.2 Press Release dated July 24, 1997
<PAGE>
[CONCEPTUS LOGO]
EXHIBIT 99.1
Contacts:
Conceptus, Inc.
Kathryn Tunstall, President & CEO
Sanford Fitch,
Senior Vice President & CFO
(415) 802-7240
FOR IMMEDIATE RELEASE
CONCEPTUS INITIATES INTERNATIONAL LAUNCH OF
ERA RESECTOSCOPE SHEATH
FOR MINIMALLY INVASIVE GYNECOLOGIC SURGERY
SAN CARLOS, CA, JULY 21, 1997 - Conceptus, Inc. (NASDAQ: CPTS) today announced
the commencement of international sales of its ERA (Endometrial Resection and
Ablation) Resectoscope Sheath. The device enables physicians -- for the first
time -- to use isotonic (physiologic) irrigating solutions with existing
electrosurgical equipment to significantly enhance the safety of therapeutic
hysteroscopy. This procedure provides a less invasive alternative to
hysterectomy in the treatment of uterine disorders such as dysfunctional
uterine bleeding (DUB), fibroids and polyps.
Traditionally, therapeutic hysteroscopy requires the use of hyptonic (low salt)
solutions which, if absorbed in large amounts into the blood stream, can create
dilutional hyponatremia (low salt content in the blood). This can lead to
serious heart, lung, and brain disorders, including coma and death. By
allowing the use of isotonic solutions, the ERA Resectoscope Sheath eliminates
the risk and complications of hyponatremia and should allow for the expanded
use of this clinically proven, minimally invasive procedure.
"The initiation of sales abroad for the ERA Resectoscope Sheath represents an
important marketing and business development milestone that allows us to
further establish Conceptus's international presence in the field of
interventional gynecology", stated Kathryn Tunstall, President and CEO of
Conceptus. "The ability for physicians to now perform clinically proven
therapeutic hysteroscopy procedures without the potentially fatal risks of
hypotonic fluid absorption represents a significant step in women's
healthcare."
<PAGE>
The initial roll out of the ERA Resectoscope Sheath will utilize Conceptus's
existing sales representatives in France and the United Kingdom, with planned
expansion to additional countries over the next three months. Conceptus
submitted a 510(k) application to the U.S. Food and Drug Administration for
marketing clearance of the ERA Resectoscope Sheath in June of this year.
Both the ERA Resectoscope Sheath for gynecology and the FUTURA Resectoscope
Sheath for urological applications were acquired by Conceptus in November 1996.
Earlier this year, the Company received FDA 510(k) clearance of the FUTURA
Resectoscope Sheath for use in transurethral resection and ablation within the
urethra, prostate and bladder.
Conceptus Inc. designs, develops and markets innovative interventional medical
devices for use in reproductive medicine. The Company's inital focus is on the
development of systems to improve the diagnosis and treatment of fallopian tube
diseases and disorders, a primary cause of infertility. The Company is
introducing a novel technology designed to improve the safety and ease-of-use
of therapeutic hysteroscopy, a growing, less invasive alternative to
hysterectomy. The Company is also developing a non-surgical approach to
fallopian tube sterilization, the most commonly performed contraceptive
procedure worldwide.
###
Except for the historical information contained herein, the matters discussed
in this press release are forward-looking statements, the accuracy of which is
necessarily subject to risks and uncertainties. The receipt of regulatory
approvals, clinical efficacy of and market demand for products, among other
matters discussed in this release, may differ significantly from the discussion
of such matters in the forward-looking statements. Such differences may be
based upon factors within Conceptus' control, such as strategic planning
decisions by management and re-allocation of internal resources, or on factors
outside of Conceptus' control, such as delays by regulatory authorities,
scientific advances by Conceptus or third parties and introduction of
competitive products, as well as those factors set forth in the Company's
Annual Report on Form 10-K for the year ended December 31, 1996, and other
filings with the Securities and Exchange Commission."
<PAGE>
[CONCEPTUS LOGO]
EXHIBIT 99.2
Contact: Sanford Fitch
Chief Financial Officer
Conceptus, Inc.
(415) 802-7240
FOR IMMEDIATE RELEASE
CONCEPTUS REPORTS SECOND QUARTER 1997 RESULTS
SAN CARLOS, CA., JULY 24, 1997 -- Conceptus, Inc. (NASDAQ: CPTS) announced
today the financial results for its second quarter of 1997. The Company
reported second quarter net sales of $424,000, a 304% increase over the same
period last year. The Company also reported a net loss of $2,778,000 or $0.30
loss per share for the second quarter compared with a net loss of $1,629,000,
or $0.18 loss per share for the same period last year. For the six months
ended June 30, 1997, the Company reported a net loss of $5,574,000, or $0.60
loss per share, on revenues of $701,000. This is compared to a loss of
$3,094,000, or $0.37 loss per share, on revenues of $187,000 for the same
period last year.
Revenues for the first half of 1997 consisted mainly of T-TAC (Transcervical
Tubal Access Catheter) products distributed through a partnership with
Mallinckrodt Group Inc.(NYSE: MKG). "Conceptus is in the process of beginning
the launch of our new ERA Resectoscope Sheath product line" said Kathryn
Tunstall, Conceptus's President and CEO "and we expect to see revenues from
this product line in the second half of the year. The initial launch for
gynecology applications will occur outside of the U.S. The product will be
introduced in the U.S. once required FDA approvals have been obtained." The
Company is in discussions with potential distributors of the urological
resectoscope sheath, FuTURa. The Company also intends to begin a controlled
roll-out of its STARRT Falloposcopy product line outside of the U.S. in the
second half of the year. In the U.S. Conceptus will establish several Centers
of Excellence to train interventional gynecologists in the use of Conceptus's
falloposcopy system beginning in the second half of 1997.
Conceptus, Inc. designs, develops and markets innovative interventional medical
devices for use in reproductive medicine. The Company's initial focus is on
the development of systems to improve the diagnosis and treatment of fallopian
tube diseases and disorders, a primary cause of infertility. The Company is
introducing a novel technology designed to improve the safety and ease-of-use
of therapeutic hysteroscopy, a growing, less-invasive alternative to
hysterectomy. The Company is also developing a non-surgical approach to
fallopian tube sterilization, the most commonly performed contraceptive
procedure worldwide.
Except for the historical information contained herein, the matters discussed
in this press release are forward-looking statements, the accuracy of which is
necessarily subject to risks and uncertainties.
<PAGE>
The receipt of regulatory approvals, results of product development programs,
clinical efficacy of and market demand for products, among other matters
discussed in this release, may differ significantly from the discussion of
such matters in the forward-looking statements. Such differences may be
based upon factors within Conceptus's control, such as strategic planning
decisions by management and reallocation of internal resources, or on factors
outside of Conceptus's control, such as delays by regulatory authorities,
scientific advances by Conceptus or third parties and introduction of
competitive products, as well as those factors discussed in the Company's
Form 10-K for the year ended December 31, 1996 and other filings with the
Securities and Exchange Commission.
<PAGE>
CONCEPTUS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
(IN THOUSANDS OF DOLLARS, EXCEPT SHARE DATA)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
-------------------------------------- June 30,
June 30, March 31, June 30, ----------------------
1997 1997 1996 1997 1996
-------- --------- -------- -------- -------
<S> <C> <C> <C> <C> <C>
Net sales 424 277 105 701 187
Cost of sales 752 442 235 1,194 394
-------- --------- -------- -------- -------
Gross profit (328) (165) (130) (493) (207)
Operating expenses:
R&D and regulatory 1,411 1,558 915 2,969 1,703
Sales and marketing 798 803 742 1,601 1,347
General and administrative 685 762 458 1,447 845
-------- --------- -------- -------- -------
Total operating expenses 2,894 3,123 2,115 6,017 3,895
-------- --------- -------- -------- -------
Operating loss (3,222) (3,288) (2,245) (6,510) (4,102)
Interest income & other, net 447 496 616 943 1,008
Interest expense (3) (4) - (7) -
-------- --------- -------- -------- -------
Net loss (2,778) (2,796) (1,629) (5,574) (3,094)
-------- --------- -------- -------- -------
-------- --------- -------- -------- -------
Net loss per share $ (0.30) $ (0.30) $ (0.18) $ (0.60) $ (0.37)
-------- --------- -------- -------- -------
-------- --------- -------- -------- -------
Shares used in computing
net loss per share 9,348 9,226 9,127 9,287 8,382
-------- --------- -------- -------- -------
-------- --------- -------- -------- -------
</TABLE>
Certain amounts have been reclassified to conform to the current presentation.
<TABLE>
<CAPTION>
CONDENSED BALANCE SHEET DATA
(IN THOUSANDS)
June 30, December 31,
1997 1996
----------- ------------
(Unaudited)
<S> <C> <C>
Cash, cash equivalents and short and long term
investments 32,574 39,021
Inventory 151 182
Trade accounts receivable 361 105
Total current assets 34,253 35,746
PP&E, net 1,036 543
Total assets 35,393 40,093
Accounts payable & accruals 1,610 2,345
Total current liabilities 1,681 2,464
Accumulated deficit (29,247) (23,673)
Stockholders' equity (net capital deficiency) 33,705 37,595
</TABLE>
