UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2019
OR
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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 001-36352
AKEBIA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
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20-8756903 |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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245 First Street, Cambridge, MA |
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02142 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (617) 871-2098
n/a
(Former name, former address and formal fiscal year, if changed since last report)
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Securities registered pursuant to Section 12(b) of the Act: |
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Title of each class Common Stock, par value $0.00001 per share |
Trading symbol(s) AKBA |
Name of each exchange on which registered The Nasdaq Global Market |
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 ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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☐ |
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Accelerated filer |
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☒ |
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Non-accelerated filer |
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☐ |
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Smaller reporting company |
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☐ |
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Emerging growth company |
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☒ |
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. ☒
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
|
Outstanding at October 31, 2019 |
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118,943,016 |
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that are being made pursuant to the provisions of the U.S. Private Securities Litigation Reform Act of 1995 with the intention of obtaining the benefits of the “safe harbor” provisions of that Act. All statements contained in this Quarterly Report on Form 10‑Q other than statements of historical fact are forward‑looking statements. These forward-looking statements may be accompanied by words such as “anticipate,” “believe,” “build,” “can,” “contemplate,” “continue,” “could,” “should,” “designed,” “estimate,” “project,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “strategy,” “seek,” “target,” “will,” “would,” and other words and terms of similar meaning, but the absence of these words does not necessarily mean that a statement is not forward‑looking. These forward-looking statements include, but are not limited to, statements about:
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• |
our expectations with respect to (i) the anticipated financial impact and potential benefits to us related to our merger with Keryx Biopharmaceuticals, Inc., or Keryx, that was completed on December 12, 2018, or the Merger, (ii) integration of the businesses subsequent to the Merger, and (iii) other matters related to the Merger; |
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• |
the timing, investment and associated activities involved in commercializing Auryxia; |
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• |
the potential therapeutic applications of the hypoxia-inducible factor, or HIF, pathway; |
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• |
our pipeline, including its potential, and our research activities; |
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• |
the potential therapeutic benefits, safety profile, and effectiveness of our product candidates, including the potential for vadadustat to set a new standard of care in the treatment of anemia due to chronic kidney disease; |
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• |
the potential indications, demand and market potential and acceptance of our product and product candidates, including our estimates regarding the potential market opportunity for Auryxia, vadadustat or any other product candidates and the size of eligible patient populations; |
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• |
our competitive position, including estimates, developments and projections relating to our competitors and their products and product candidates, and our industry; |
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• |
our expectations, projections and estimates regarding our costs, expenses, revenues, capital requirements, need for additional capital, financing our future cash needs, capital resources, cash flows, financial performance, profitability, tax obligations, liquidity, growth, contractual obligations, the period of time our cash resources and collaboration funding will fund our current operating plan, internal control over financial reporting, and disclosure controls and procedures; |
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• |
the timing of the availability and disclosure of clinical trial data and results; |
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• |
our and our collaborators’ strategy, plans and expectations with respect to the development, manufacturing, commercialization, launch, marketing and sale of our product candidates, and the associated timing thereof; |
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• |
the designs of our studies, and the type of information and data expected from our studies and the expected benefits thereof; |
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• |
the timing of or likelihood of regulatory filings and approvals, including labeling or other restrictions; |
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• |
our ability to maintain any marketing authorizations we currently hold or will obtain, including our marketing authorizations for Auryxia and Fexeric and our ability to complete post-marketing requirements with respect thereto; |
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• |
our ability to negotiate, secure and maintain adequate pricing, coverage and reimbursement terms and processes on a timely basis, or at all, with third-party payors for Auryxia or any other product candidate that may be approved; |
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• |
the targeted timing of enrollment of our clinical trials; |
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• |
the timing of initiation of our clinical trials and plans to conduct preclinical and clinical studies in the future; |
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• |
the timing and amounts of payments from or to our collaborators and licensees, and the anticipated arrangements and benefits under our collaboration and license agreements, including with respect to milestones and royalties; |
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• |
our intellectual property position, including obtaining and maintaining patents, and the timing, outcome and impact of administrative, regulatory, legal and other proceedings relating to our patents and other proprietary and intellectual property rights, as well as Abbreviated New Drug Applications filed by generic drug manufacturers and potential U.S. Food and Drug Administration approval thereof, and associated patent infringement suits that we have filed or may file, or other actions that we may take against such companies, and the timing and resolution thereof; |
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• |
expected reliance on third parties, including with respect to the development, manufacturing, supply and commercialization of our product and product candidates; |
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• |
accounting standards and estimates, their impact, and their expected timing of completion; |
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• |
estimated periods of performance of key contracts; |
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• |
cybersecurity; |
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• |
insurance coverage; |
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• |
our employees, including our management team, employee compensation, employee relations, and our ability to attract and retain high quality employees; |
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• |
the implementation of our business model, current operating plan, and strategic plans for our business, product candidates and technology, and business development opportunities including potential collaborations, alliances, mergers, acquisitions or licensing of assets; and |
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• |
the timing, outcome and impact of current and any future legal proceedings. |
These forward-looking statements involve risks and uncertainties, including those that are described in Part II, Item 1A. Risk Factors included in this Quarterly Report on Form 10-Q and elsewhere in this Quarterly Report on Form 10-Q, that could cause our actual results, financial condition, performance or achievements to be materially different from those indicated in these forward-looking statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to publicly update or revise these forward-looking statements for any reason. Unless otherwise stated, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
This Quarterly Report on Form 10-Q also contains estimates and other information concerning our industry and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Unless otherwise expressly stated, we obtained this industry, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
In this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise requires, references to “Akebia,” “we,” “us,” “our,” “the Company,” and similar references refer to Akebia Therapeutics, Inc. and, where appropriate, its subsidiaries, including Keryx. The trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. All website addresses given in this Quarterly Report on Form 10-Q are for information only and are not intended to be an active link or to incorporate any website information into this document.
Table of Contents
AKEBIA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share data)
|
|
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September 30, |
|
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December 31, |
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||
|
|
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2019 |
|
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2018 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
122,886 |
|
|
$ |
104,644 |
|
|
Available for sale securities |
|
|
22,727 |
|
|
|
216,996 |
|
|
Inventory |
|
|
115,987 |
|
|
|
114,245 |
|
|
Accounts receivable, net |
|
|
29,654 |
|
|
|
16,666 |
|
|
Prepaid expenses and other current assets |
|
|
7,754 |
|
|
|
15,724 |
|
|
Total current assets |
|
|
299,008 |
|
|
|
468,275 |
|
|
Property and equipment, net |
|
|
12,799 |
|
|
|
8,023 |
|
|
Operating lease assets |
|
|
30,141 |
|
|
|
— |
|
|
Goodwill |
|
|
55,053 |
|
|
|
55,053 |
|
|
Other intangible assets, net |
|
|
300,312 |
|
|
|
328,153 |
|
|
Other assets |
|
|
97,907 |
|
|
|
137,036 |
|
|
Total assets |
|
$ |
795,220 |
|
|
$ |
996,540 |
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
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Accounts payable |
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$ |
64,362 |
|
|
$ |
42,796 |
|
|
Accrued expenses and other current liabilities |
|
|
126,644 |
|
|
|
150,917 |
|
|
Debt |
|
|
— |
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|
|
15,000 |
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|
Short-term deferred revenue |
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|
32,142 |
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|
|
56,980 |
|
|
Total current liabilities |
|
|
223,148 |
|
|
|
265,693 |
|
|
Deferred rent, net of current portion |
|
|
— |
|
|
|
3,006 |
|
|
Deferred revenue, net of current portion |
|
|
43,887 |
|
|
|
55,709 |
|
|
Operating lease liabilities, net of current portion |
|
|
28,811 |
|
|
|
— |
|
|
Deferred tax liabilities |
|
|
1,752 |
|
|
|
6,631 |
|
|
Other non-current liabilities |
|
|
30,060 |
|
|
|
29,573 |
|
|
Total liabilities |
|
|
327,658 |
|
|
|
360,612 |
|
|
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Preferred stock $0.00001 par value, 25,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2019 and December 31, 2018 |
|
|
— |
|
|
|
— |
|
|
Common stock $0.00001 par value; 175,000,000 shares authorized at September 30, 2019 and December 31, 2018; 118,863,735 and 116,887,518 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
|
|
1 |
|
|
|
1 |
|
|
Additional paid-in capital |
|
|
1,167,126 |
|
|
|
1,150,583 |
|
|
Accumulated other comprehensive income (loss) |
|
|
6 |
|
|
|
(261 |
) |
|
Accumulated deficit |
|
|
(699,571 |
) |
|
|
(514,395 |
) |
|
Total stockholders' equity |
|
|
467,562 |
|
|
|
635,928 |
|
|
Total liabilities and stockholders' equity |
|
$ |
795,220 |
|
|
$ |
996,540 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
5
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
|
|
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Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
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September 30, |
|
|
September 30, |
|
||||||||||
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
||||
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
30,004 |
|
|
$ |
— |
|
|
$ |
82,204 |
|
|
$ |
— |
|
|
License, collaboration and other revenue |
|
|
61,973 |
|
|
|
53,169 |
|
|
|
183,242 |
|
|
|
147,892 |
|
|
Total revenues |
|
|
91,977 |
|
|
|
53,169 |
|
|
|
265,446 |
|
|
|
147,892 |
|
|
Cost of goods sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
29,162 |
|
|
|
— |
|
|
|
79,888 |
|
|
|
— |
|
|
Amortization of intangibles |
|
|
9,101 |
|
|
|
— |
|
|
|
27,301 |
|
|
|
— |
|
|
Total cost of goods sold |
|
|
38,263 |
|
|
|
— |
|
|
|
107,189 |
|
|
|
— |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
74,512 |
|
|
|
70,634 |
|
|
|
242,557 |
|
|
|
203,955 |
|
|
Selling, general and administrative |
|
|
34,178 |
|
|
|
10,378 |
|
|
|
104,537 |
|
|
|
31,940 |
|
|
License expense |
|
|
929 |
|
|
|
— |
|
|
|
2,560 |
|
|
|
— |
|
|
Total operating expenses |
|
|
109,619 |
|
|
|
81,012 |
|
|
|
349,654 |
|
|
|
235,895 |
|
|
Operating loss |
|
|
(55,905 |
) |
|
|
(27,843 |
) |
|
|
(191,397 |
) |
|
|
(88,003 |
) |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
228 |
|
|
|
1,780 |
|
|
|
1,582 |
|
|
|
4,417 |
|
|
Other income (expense) |
|
|
(185 |
) |
|
|
16 |
|
|
|
(240 |
) |
|
|
52 |
|
|
Net loss before income taxes |
|
|
(55,862 |
) |
|
|
(26,047 |
) |
|
|
(190,055 |
) |
|
|
(83,534 |
) |
|
Benefit from income taxes |
|
|
(1,277 |
) |
|
|
— |
|
|
|
(4,879 |
) |
|
|
— |
|
|
Net loss |
|
$ |
(54,585 |
) |
|
$ |
(26,047 |
) |
|
$ |
(185,176 |
) |
|
$ |
(83,534 |
) |
|
Net loss per share - basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.46 |
) |
|
$ |
(1.57 |
) |
|
$ |
(1.54 |
) |
|
Weighted-average number of common shares - basic and diluted |
|
|
118,863,063 |
|
|
|
57,027,598 |
|
|
|
118,071,674 |
|
|
|
54,207,973 |
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(54,585 |
) |
|
$ |
(26,047 |
) |
|
$ |
(185,176 |
) |
|
$ |
(83,534 |
) |
|
Other comprehensive gain (loss) - unrealized gain (loss) on debt securities |
|
|
(17 |
) |
|
|
50 |
|
|
|
267 |
|
|
|
33 |
|
|
Total comprehensive loss |
|
$ |
(54,602 |
) |
|
$ |
(25,997 |
) |
|
$ |
(184,909 |
) |
|
$ |
(83,501 |
) |
See accompanying notes to unaudited condensed consolidated financial statements.
6
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(in thousands, except share data)
|
|
|
Common Stock |
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
Total |
|
|||||||
|
|
|
Number of Shares |
|
|
$0.00001 Par Value |
|
|
Paid-In Capital |
|
|
Unrealized Gain/(Loss) |
|
|
Accumulated Deficit |
|
|
Stockholders' Equity |
|
||||||
|
Balance at December 31, 2017 |
|
|
47,612,619 |
|
|
$ |
— |
|
|
$ |
493,823 |
|
|
$ |
(442 |
) |
|
$ |
(370,807 |
) |
|
$ |
122,574 |
|
|
Issuance of common stock, net of issuance costs |
|
|
9,194,306 |
|
|
|
— |
|
|
|
95,416 |
|
|
|
— |
|
|
|
— |
|
|
|
95,416 |
|
|
Proceeds from sale of stock under employee stock purchase plan |
|
|
17,569 |
|
|
|
— |
|
|
|
218 |
|
|
|
— |
|
|
|
— |
|
|
|
218 |
|
|
Exercise of options |
|
|
21,363 |
|
|
|
— |
|
|
|
182 |
|
|
|
— |
|
|
|
— |
|
|
|
182 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,232 |
|
|
|
— |
|
|
|
— |
|
|
|
2,232 |
|
|
Restricted stock unit vesting |
|
|
11,613 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(108 |
) |
|
|
— |
|
|
|
(108 |
) |
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(23,418 |
) |
|
|
(23,418 |
) |
|
Balance at March 31, 2018 |
|
|
56,857,470 |
|
|
$ |
— |
|
|
$ |
591,871 |
|
|
$ |
(550 |
) |
|
$ |
(394,225 |
) |
|
$ |
197,096 |
|
|
Proceeds from sale of stock under employee stock purchase plan |
|
|
— |
|
|
|
— |
|
|
|
(3 |
) |
|
|
— |
|
|
|
— |
|
|
|
(3 |
) |
|
Exercise of options |
|
|
43,041 |
|
|
|
— |
|
|
|
314 |
|
|
|
— |
|
|
|
— |
|
|
|
314 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,494 |
|
|
|
— |
|
|
|
— |
|
|
|
2,494 |
|
|
Restricted stock unit vesting |
|
|
13,375 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
91 |
|
|
|
— |
|
|
|
91 |
|
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(34,069 |
) |
|
|
(34,069 |
) |
|
Balance at June 30, 2018 |
|
|
56,913,886 |
|
|
$ |
— |
|
|
$ |
594,676 |
|
|
$ |
(459 |
) |
|
$ |
(428,294 |
) |
|
$ |
165,923 |
|
|
Issuance of common stock, net of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
36 |
|
|
|
— |
|
|
|
— |
|
|
|
36 |
|
|
Proceeds from sale of stock under employee stock purchase plan |
|
|
31,199 |
|
|
|
— |
|
|
|
267 |
|
|
|
— |
|
|
|
— |
|
|
|
267 |
|
|
Exercise of options |
|
|
101,478 |
|
|
|
— |
|
|
|
59 |
|
|
|
— |
|
|
|
— |
|
|
|
59 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,252 |
|
|
|
— |
|
|
|
— |
|
|
|
2,252 |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
50 |
|
|
|
— |
|
|
|
50 |
|
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(26,047 |
) |
|
|
(26,047 |
) |
|
Balance at September 30, 2018 |
|
|
57,046,563 |
|
|
$ |
— |
|
|
$ |
597,290 |
|
|
$ |
(409 |
) |
|
$ |
(454,341 |
) |
|
$ |
142,540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2018 |
|
|
116,887,518 |
|
|
$ |
1 |
|
|
$ |
1,150,583 |
|
|
$ |
(261 |
) |
|
$ |
(514,395 |
) |
|
$ |
635,928 |
|
|
Proceeds from sale of stock under employee stock purchase plan |
|
|
39,977 |
|
|
|
— |
|
|
|
188 |
|
|
|
— |
|
|
|
— |
|
|
|
188 |
|
|
Exercise of options |
|
|
62,204 |
|
|
|
— |
|
|
|
365 |
|
|
|
— |
|
|
|
— |
|
|
|
365 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,094 |
|
|
|
— |
|
|
|
— |
|
|
|
2,094 |
|
|
Restricted stock unit vesting |
|
|
132,563 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
225 |
|
|
|
— |
|
|
|
225 |
|
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(72,421 |
) |
|
|
(72,421 |
) |
|
Balance at March 31, 2019 |
|
|
117,122,262 |
|
|
$ |
1 |
|
|
$ |
1,153,230 |
|
|
$ |
(36 |
) |
|
$ |
(586,816 |
) |
|
$ |
566,379 |
|
|
Issuance of common stock, net of issuance costs |
|
|
1,384,520 |
|
|
|
— |
|
|
|
9,035 |
|
|
|
— |
|
|
|
— |
|
|
|
9,035 |
|
|
Exercise of options |
|
|
300,592 |
|
|
|
— |
|
|
|
195 |
|
|
|
— |
|
|
|
— |
|
|
|
195 |
|
|
Retired shares |
|
|
(55,324 |
) |
|
|
— |
|
|
|
(426 |
) |
|
|
— |
|
|
|
— |
|
|
|
(426 |
) |
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,284 |
|
|
|
— |
|
|
|
— |
|
|
|
2,284 |
|
|
Restricted stock unit vesting |
|
|
35,251 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
59 |
|
|
|
— |
|
|
|
59 |
|
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(58,170 |
) |
|
|
(58,170 |
) |
|
Balance at June 30, 2019 |
|
|
118,787,301 |
|
|
$ |
1 |
|
|
$ |
1,164,318 |
|
|
$ |
23 |
|
|
$ |
(644,986 |
) |
|
$ |
519,356 |
|
|
Proceeds from sale of stock under employee stock purchase plan |
|
|
47,553 |
|
|
|
— |
|
|
|
195 |
|
|
|
— |
|
|
|
— |
|
|
|
195 |
|
|
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,613 |
|
|
|
— |
|
|
|
— |
|
|
|
2,613 |
|
|
Restricted stock unit vesting |
|
|
28,881 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Unrealized gain/loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(17 |
) |
|
|
— |
|
|
|
(17 |
) |
|
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(54,585 |
) |
|
|
(54,585 |
) |
|
Balance at September 30, 2019 |
|
|
118,863,735 |
|
|
$ |
1 |
|
|
$ |
1,167,126 |
|
|
$ |
6 |
|
|
$ |
(699,571 |
) |
|
$ |
467,562 |
|
See accompanying notes to unaudited condensed consolidated financial statements
7
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
|
|
|
Nine Months Ended |
|
|||||
|
|
|
September 30, 2019 |
|
|
September 30, 2018 |
|
||
|
Operating activities: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(185,176 |
) |
|
$ |
(83,534 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,659 |
|
|
|
638 |
|
|
Amortization of intangibles |
|
|
27,301 |
|
|
|
— |
|
|
Amortization of premium/discount on investments |
|
|
(795 |
) |
|
|
(698 |
) |
|
Non-cash interest expense |
|
|
508 |
|
|
|
— |
|
|
Non-cash operating lease expense |
|
|
(1,673 |
) |
|
|
— |
|
|
Fair value write-up of inventory sold |
|
|
51,604 |
|
|
|
— |
|
|
Write-down of inventory to net realizable value |
|
|
5,968 |
|
|
|
— |
|
|
Stock-based compensation |
|
|
6,991 |
|
|
|
6,978 |
|
|
Deferred income taxes |
|
|
(4,879 |
) |
|
|
— |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(12,988 |
) |
|
|
33,528 |
|
|
Inventory |
|
|
(28,565 |
) |
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
9,415 |
|
|
|
(346 |
) |
|
Other long-term assets |
|
|
3,145 |
|
|
|
67 |
|
|
Accounts payable |
|
|
26,438 |
|
|
|
5,686 |
|
|
Accrued expense |
|
|
(29,176 |
) |
|
|
42,118 |
|
|
Operating lease liabilities |
|
|
1,577 |
|
|
|
— |
|
|
Deferred revenue |
|
|
(36,660 |
) |
|
|
(28,101 |
) |
|
Deferred rent |
|
|
— |
|
|
|
(131 |
) |
|
Net cash used in operating activities |
|
|
(165,306 |
) |
|
|
(23,795 |
) |
|
Investing activities: |
|
|
|
|
|
|
|
|
|
Purchase of equipment |
|
|
(6,435 |
) |
|
|
(776 |
) |
|
Proceeds from the maturities of available for sale securities |
|
|
130,610 |
|
|
|
180,091 |
|
|
Proceeds from sales of available for sale securities |
|
|
64,721 |
|
|
|
13,000 |
|
|
Purchase of available for sale securities |
|
|
— |
|
|
|
(172,438 |
) |
|
Net cash provided by investing activities |
|
|
188,896 |
|
|
|
19,877 |
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock, net of issuance costs |
|
|
9,035 |
|
|
|
95,453 |
|
|
Proceeds from the sale of stock under employee stock purchase plan |
|
|
383 |
|
|
|
482 |
|
|
Proceeds from the exercise of stock options |
|
|
560 |
|
|
|
555 |
|
|
Retirement of treasury stock |
|
|
(426 |
) |
|
|
— |
|
|
Payments on debt |
|
|
(15,000 |
) |
|
|
— |
|
|
Payments on capital lease obligations |
|
|
— |
|
|
|
(13 |
) |
|
Net cash provided by (used in) financing activities |
|
|
(5,448 |
) |
|
|
96,477 |
|
|
Increase in cash, cash equivalents, and restricted cash |
|
|
18,142 |
|
|
|||