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Delaware
|
|
001-37474
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56-2463152
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(State or Other Jurisdiction
of Incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.00001 par value per share
|
CFMS
|
The Nasdaq Global Select Market
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
|
Emerging growth company
|
þ
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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þ
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Item 2.02
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Results of Operations and Financial Condition
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Item 9.01
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Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit No.
|
|
Description
|
|
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|
|
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|
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CONFORMIS, INC.
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||
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|||
Date: March 2, 2020
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|
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By:
|
|
/s/ Robert Howe
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|
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|
|
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Robert Howe
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|
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|
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Chief Financial Officer
|
•
|
Total revenue of $19.9 million, down 10% year-over-year on a reported basis and 9% on a constant currency basis
|
•
|
Product revenue of $19.7 million, down 10% year-over-year on a reported and constant currency basis
|
–
|
U.S. product revenue of $17.2 million, down 11% year-over-year
|
–
|
Rest-of-world product revenue of $2.5 million, up 0.5% year-over-year on a reported basis and 4% on a constant currency basis
|
•
|
Royalty revenue of $0.2 million, up 9% year-over-year
|
•
|
Gross margin of 49%, flat year-over-year
|
•
|
Total revenue of $77.4 million, down 14% year-over-year on a reported basis, including a royalty settlement of $10.5 million in the third quarter of 2018, and 13% on a constant currency basis
|
•
|
Product revenue of $76.6 million, down 3% year-over-year on a reported basis and 2% on a constant currency basis
|
–
|
U.S. product revenue of $67.2 million, down 1% year-over-year
|
–
|
Rest-of-world product revenue of $9.5 million, down 10% year-over-year on a reported basis and 6% on a constant currency basis
|
•
|
Royalty revenue of $0.8 million, down 93% year-over-year, as a result of a one-time royalty settlement of $10.5 million in the third quarter of 2018; excluding the settlement, royalty revenue was up 18% year-over-year.
|
•
|
Gross margin of 47%, a decrease of 700 basis points year-over-year due to the royalty settlement in the third quarter of 2018; excluding the royalty settlement, gross margin was flat year-over-year.
|
•
|
Conformis expects product revenue growth for 2020 to be in the range of 3% - 6%
|
|
Three Months Ended
December 31, |
Increase/(decrease)
|
||||||||||||||||
($, in thousands)
|
2019
|
2018
|
$ Change
|
% Change
|
% Change
|
|||||||||||||
|
|
|
|
(as reported)
|
(constant currency)
|
|||||||||||||
United States
|
$
|
17,225
|
|
|
$
|
19,410
|
|
|
$
|
(2,185
|
)
|
|
(11
|
)
|
%
|
(11
|
)
|
%
|
Rest of world
|
|
2,506
|
|
|
|
2,494
|
|
|
|
12
|
|
|
—
|
|
%
|
4
|
|
%
|
Product revenue
|
|
19,731
|
|
|
|
21,904
|
|
|
|
(2,173
|
)
|
|
(10
|
)
|
%
|
(10
|
)
|
%
|
Royalty revenue
|
|
158
|
|
|
|
145
|
|
|
|
13
|
|
|
9
|
|
%
|
9
|
|
%
|
Total revenue
|
$
|
19,889
|
|
|
$
|
22,049
|
|
|
$
|
(2,160
|
)
|
|
(10
|
)
|
%
|
(9
|
)
|
%
|
|
Twelve Months Ended December 31,
|
Increase/(decrease)
|
||||||||||||||||
($, in thousands)
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
% Change
|
||||||||||
|
|
|
|
|
|
|
|
|
|
(as reported)
|
(constant currency)
|
|||||||
United States
|
$
|
67,151
|
|
|
$
|
68,062
|
|
|
$
|
(911
|
)
|
|
(1
|
)
|
%
|
(1
|
)
|
%
|
Rest of world
|
9,498
|
|
|
10,565
|
|
|
(1,067
|
)
|
|
(10
|
)
|
%
|
(6
|
)
|
%
|
|||
Product revenue
|
76,649
|
|
|
78,627
|
|
|
(1,978
|
)
|
|
(3
|
)
|
%
|
(2
|
)
|
%
|
|||
Royalty revenue
|
780
|
|
|
11,162
|
|
|
(10,382
|
)
|
|
(93
|
)
|
%
|
(93
|
)
|
%
|
|||
Total revenue
|
$
|
77,429
|
|
|
$
|
89,789
|
|
|
$
|
(12,360
|
)
|
|
(14
|
)
|
%
|
(13
|
)
|
%
|
CONFORMIS, INC. AND SUBSIDIARIES
|
|
||||||||||||||||
Consolidated Statements of Operations
|
|
||||||||||||||||
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|
||||||||||||||||
(in thousands, except share and per share data)
|
|
||||||||||||||||
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|||||||||||
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Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
||||||||||||||
|
2019
|
2018
|
|
2019
|
2018
|
||||||||||||
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
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|
||||||||
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product
|
$
|
19,731
|
|
|
$
|
21,904
|
|
|
|
$
|
76,649
|
|
|
$
|
78,627
|
|
|
Royalty
|
158
|
|
|
145
|
|
|
|
780
|
|
|
11,162
|
|
|
||||
Total revenue
|
19,889
|
|
|
22,049
|
|
|
|
77,429
|
|
|
89,789
|
|
|
||||
Cost of revenue
|
10,233
|
|
|
11,181
|
|
|
|
40,692
|
|
|
41,304
|
|
|
||||
Gross profit
|
9,656
|
|
|
10,868
|
|
|
|
36,737
|
|
|
48,485
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing
|
7,283
|
|
|
9,682
|
|
|
|
28,514
|
|
|
38,955
|
|
|
||||
Research and development
|
3,055
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|
3,458
|
|
|
|
12,457
|
|
|
16,869
|
|
|
||||
General and administrative
|
5,112
|
|
|
6,098
|
|
|
|
20,895
|
|
|
24,622
|
|
|
||||
Goodwill impairment
|
—
|
|
|
—
|
|
|
|
—
|
|
|
6,731
|
|
|
||||
Total operating expenses
|
15,450
|
|
|
19,238
|
|
|
|
61,866
|
|
|
87,177
|
|
|
||||
Loss from operations
|
(5,794
|
)
|
|
(8,370
|
)
|
|
|
(25,129
|
)
|
|
(38,692
|
)
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income
|
74
|
|
|
184
|
|
|
|
330
|
|
|
659
|
|
|
||||
Interest expense
|
(579
|
)
|
|
(1,067
|
)
|
|
|
(2,942
|
)
|
|
(3,356
|
)
|
|
||||
Foreign currency exchange transaction (loss) income
|
876
|
|
|
(630
|
)
|
|
|
(692
|
)
|
|
(1,915
|
)
|
|
||||
Total other (expenses) income, net
|
371
|
|
|
(1,513
|
)
|
|
|
(3,304
|
)
|
|
(4,612
|
)
|
|
||||
Loss before income taxes
|
(5,423
|
)
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|
(9,883
|
)
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|
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(28,433
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)
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(43,304
|
)
|
|
||||
Income tax provision
|
10
|
|
|
(13
|
)
|
|
|
45
|
|
|
61
|
|
|
||||
|
|
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|
||||
Net loss
|
$
|
(5,433
|
)
|
|
$
|
(9,870
|
)
|
|
|
$
|
(28,478
|
)
|
|
$
|
(43,365
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted
|
$
|
(0.08
|
)
|
|
$
|
(0.16
|
)
|
|
|
$
|
(0.44
|
)
|
|
$
|
(0.74
|
)
|
|
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted
|
65,520,222
|
|
|
60,848,875
|
|
|
|
64,122,455
|
|
|
58,886,333
|
|
|
CONFORMIS, INC. AND SUBSIDIARIES
|
|||||||||
Consolidated Balance Sheets
|
|||||||||
(in thousands, except share and per share data)
|
|||||||||
|
|
|
|
||||||
|
December 31, 2019
|
|
December 31, 2018
|
||||||
Assets
|
(unaudited)
|
|
|
||||||
Current Assets
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
26,394
|
|
|
|
$
|
16,380
|
|
|
Investments
|
—
|
|
|
|
7,245
|
|
|
||
Accounts receivable, net
|
11,066
|
|
|
|
13,244
|
|
|
||
Royalty receivable
|
165
|
|
|
|
145
|
|
|
||
Inventories
|
12,074
|
|
|
|
9,534
|
|
|
||
Prepaid expenses and other current assets
|
2,815
|
|
|
|
1,408
|
|
|
||
Total current assets
|
52,514
|
|
|
|
47,956
|
|
|
||
Property and equipment, net
|
13,356
|
|
|
|
14,439
|
|
|
||
Operating lease right-of-use assets
|
5,853
|
|
|
|
—
|
|
|
||
Other Assets
|
|
|
|
||||||
Restricted cash
|
462
|
|
|
|
462
|
|
|
||
Intangible assets, net
|
—
|
|
|
|
109
|
|
|
||
Other long-term assets
|
211
|
|
|
|
17
|
|
|
||
Total assets
|
$
|
72,396
|
|
|
|
$
|
62,983
|
|
|
|
|
|
|
||||||
Liabilities and stockholder's equity
|
|
|
|
||||||
Current liabilities
|
|
|
|
||||||
Accounts payable
|
$
|
6,920
|
|
|
|
$
|
3,445
|
|
|
Accrued expenses
|
7,135
|
|
|
|
7,930
|
|
|
||
Operating lease liabilities
|
1,469
|
|
|
|
—
|
|
|
||
Advance on research and development
|
2,331
|
|
|
|
—
|
|
|
||
Total current liabilities
|
17,855
|
|
|
|
11,375
|
|
|
||
Other long-term liabilities
|
1,500
|
|
|
|
616
|
|
|
||
Contract liability
|
12,000
|
|
|
|
—
|
|
|
||
Long-term debt, less debt issuance costs
|
19,623
|
|
|
|
14,792
|
|
|
||
Operating lease liabilities
|
5,071
|
|
|
|
—
|
|
|
||
Total liabilities
|
56,049
|
|
|
|
26,783
|
|
|
||
Commitments and contingencies
|
|
|
|
|
|
|
|
||
Stockholders' equity
|
|
|
|
||||||
Preferred stock, $0.00001 par value:
|
|
|
|
||||||
Authorized: 5,000,000 shares authorized at December 31, 2019 and December 31, 2018; no shares issued and outstanding as of December 31, 2019 and December 31, 2018
|
—
|
|
|
|
—
|
|
|
||
Common stock, $0.00001 par value:
|
|
|
|
||||||
Authorized: 200,000,000 shares authorized at December 31, 2019 and December 31, 2018; 70,427,400 and 65,290,879 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively
|
1
|
|
|
|
1
|
|
|
||
Additional paid-in capital
|
521,356
|
|
|
|
513,336
|
|
|
||
Accumulated deficit
|
(504,145
|
)
|
|
|
(475,667
|
)
|
|
||
Accumulated other comprehensive loss
|
(865
|
)
|
|
|
(1,470
|
)
|
|
||
Total stockholders' equity
|
16,347
|
|
|
|
36,200
|
|
|
||
Total liabilities and stockholders' equity
|
$
|
72,396
|
|
|
|
$
|
62,983
|
|
|