UNITED STATES
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): March 2, 2020
Conformis, Inc.
(Exact Name of Company as Specified in Charter)
 
Delaware
 
001-37474
 
56-2463152
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

600 Technology Park Drive
Billerica, MA 01821
(Address of Principal Executive Offices) (Zip Code)

Company’s telephone number, including area code: (781) 345-9001

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
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.
þ

 







Item 2.02
Results of Operations and Financial Condition




On March 2, 2020, Conformis, Inc. issued a press release announcing its financial results for the quarter and year ended December 31, 2019. A copy of such press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference in its entirety.

The information furnished under this Item 2.02, including the press release attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise expressly stated in such filing. 

Item 9.01
Financial Statements and Exhibits.



 
(d)
Exhibits.

*Furnished herewith

Cautionary Statement Regarding Forward-Looking Statements
Statements in this Current Report on Form 8-K about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations and growth, as well as other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this Form 8-K represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.


 





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 hereunto duly authorized.

 
 
 
 
 
 
 
 
 
 
 
CONFORMIS, INC.
 
 
 
 
Date: March 2, 2020
 
 
 
By:
 
/s/ Robert Howe
 
 
 
 
 
 
Robert Howe
 
 
 
 
 
 
Chief Financial Officer





Conformis Reports Fourth Quarter and Year End 2019 Financial Results

BILLERICA, Mass., March 2, 2020 (GLOBE NEWSWIRE) - Conformis, Inc. (NASDAQ:CFMS), announced today financial results for the fourth quarter and year ended December 31, 2019.

Q4 Summary

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

2019 Summary

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.

2020 Target Revenue Growth Percentage

Conformis expects product revenue growth for 2020 to be in the range of 3% - 6%

"The revenue results we are reporting today are consistent with the results reported in our January 14 preliminary announcement. We are encouraged to see a return to growth in our OUS business for the quarter, as well as a sequential improvement in our gross margin.” said Mark Augusti, President and Chief Executive Officer. “In addition, we are proud of the recent announcement regarding our Orthopaedic Data Evaluation Panel (ODEP) 5A rating. The ODEP awarded the Conformis iTotal® CR knee replacement system a '5A' rating based on our strong evidence of implant performance over five years, including low revision rates as indicated in the UK’s National Joint Registry.”







 
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
)
%

Fourth Quarter 2019 Financial Results

Total revenue for the three-month period ended December 31, 2019 decreased $2.2 million to $19.9 million, or 10% year-over-year on a reported basis and 9% on a constant currency basis. Total revenue in the fourth quarter of 2019 and 2018 includes royalty revenue of $0.2 million and $0.1 million, respectively, related to patent license agreements.

Product revenue decreased $2.2 million to $19.7 million, or 10% year-over-year on a reported and constant currency basis. U.S. product revenue decreased $2.2 million to $17.2 million, or 11% year-over-year, and rest-of-world product revenue was $2.5 million, flat year-over-year on a reported basis and up 4% on a constant currency basis. Product revenue from sales of iTotal PS decreased $0.5 million to $7.3 million or 6% year-over-year on a reported and constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni decreased $1.7 million to $11.8 million, or 13% year-over-year on a reported basis and 12% on a constant currency basis. Conformis Hip System sales in the fourth quarter of 2019 were $0.6 million, which were all in the United States.

Total gross profit decreased $1.2 million to $9.7 million, or 49% of revenue, in the fourth quarter of 2019, compared to $10.9 million, or 49% of revenue, in the fourth quarter of 2018. Margin was flat year-over-year.

Total operating expenses decreased $3.8 million to $15.5 million, or 20% year-over-year. This decrease in expenses was driven by reductions in personnel costs and marketing programs and as part of a plan announced at the end of 2018 to reduce cash burn in 2019. In addition, selling costs were lower due to the decrease in revenue.

Net loss was $5.4 million, or $0.08 per basic share, in the fourth quarter of 2019, compared to a net loss of $9.9 million, or $0.16 per basic share, for the same period last year. Net loss in the fourth quarter of 2019 included foreign currency exchange income of $0.9 million compared to foreign currency exchange expense of $0.6 million in the same period last year. Net loss per basic share calculations assume weighted average basic shares outstanding of 65.5 million for the fourth quarter of 2019, compared to 60.8 million for the same period last year.







 
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
)
%


Fiscal Year 2019 Financial Results

Total revenue for the twelve-month period ended December 31, 2019 decreased $12.4 million to $77.4 million, or 14% year-over-year on a reported basis and 13% on a constant currency basis. Total revenue includes royalty revenue of $0.8 million for the year ended 2019 and $11.2 million for the year ended 2018 related to patent license agreements. The decrease in royalty revenue is primarily due to the royalty settlement of $10.5 million from Smith & Nephew in the third quarter of 2018.

Product revenue decreased $2.0 million to $76.6 million, or 3% year-over-year on a reported basis and 2% on a constant currency basis. U.S. product revenue decreased $0.9 million to $67.2 million, or 1% year-over-year, and rest-of-world product revenue decreased $1.1 million to $9.5 million, or 10% year-over-year on a reported basis and 6% on a constant currency basis. Product revenue from sales of iTotal PS increased $2.7 million to $28.5 million or 10% year-over-year on a reported and 11% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni decreased $5.9 million to $46.1 million, or 11% year-over-year on a reported and constant currency basis. Conformis Hip System sales for 2019 were $2.0 million, which were all in the United States.

Total gross profit decreased $11.7 million to $36.7 million, or 47% of revenue, in 2019, compared to $48.5 million, or 54% of revenue, in 2018. This 700 basis point decrease in gross margin year-over-year was driven by the $10.5 million royalty settlement in the third quarter of 2018.

Total operating expenses decreased $25.3 million to $61.9 million, or 29% year-over-year. Of this decrease in expenses, $13.7 million was driven by reductions in personnel costs, marketing programs and patent litigation expense as part of a plan announced at the end of 2018 to reduce cash burn in 2019, and $3.0 million was driven by variable costs such as expenses related to commission and revenue share. The remaining $8.6 million reduction in expense was due to the third quarter of 2018 non-cash write-off of $1.9 million of unused manufacturing equipment and a non-cash write-off of $6.7 million related to impairment of goodwill.

Net loss was $28.5 million, or $0.44 per basic share for 2019, compared to a net loss of $43.4 million, or $0.74 per basic share, for 2018. Net loss included foreign currency exchange expense of $0.7 million in 2019, compared to foreign currency exchange expense of $1.9 million in 2018. Net loss per basic share calculations assume weighted average basic shares outstanding of 64.1 million for 2019, compared to 58.9 million for 2018.






As of December 31, 2019, cash and cash equivalents and investments totaled $26.4 million, compared to $23.6 million as of December 31, 2018.


Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company's financial results or projected financial results on a non-GAAP "constant currency basis." This information estimates the impact of changes in foreign currency rates on the translation of the Company's current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company's results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis. Company management uses these non-GAAP results internally to measure operational performance.

Conference Call

As previously announced, Conformis will conduct a webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. The webcast will be live at https://edge.media-server.com/mmc/p/4n3s4un4 and at the investor relations section of the company's website at ir.conformis.com.

The online archive of the webcast will be available on the Company's website for 30 days.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit each patient's unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals. In clinical studies, Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.


For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.


Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations and growth, as well as other statements containing the words





"anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations; and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.


CONTACT:
Investor Relations
ir@conformis.com
(781) 374-5598






CONFORMIS, INC. AND SUBSIDIARIES
 
Consolidated Statements of Operations
 
 
 
(in thousands, except share and per share data)
 
 
 
 
 
 
 
 
 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
2019
2018
 
2019
2018
 
 
(unaudited)
 
 
(unaudited)
 
 
 
 
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
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating expenses
 
 
 
 
 
 
 
 
 
 
 
 
 
Sales and marketing
7,283
 
 
9,682
 
 
 
28,514
 
 
38,955
 
 
Research and development
3,055
 
 
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
)
 
(9,883
)
 
 
(28,433
)
 
(43,304
)
 
Income tax provision
10
 
 
(13
)
 
 
45
 
 
61
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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