Full Press Release Details
Zai Lab Announces Financial Results and Corporate Update for Full Year 2018
-- Zai Lab to Host Conference Call and Webcast Today at 8:30 a.m. EST--
SHANGHAI, China, Mar. 7, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited ("Zai lab" or the Company) (NASDAQ: ZLAB), a China and US-based innovative commercial stage biopharmaceutical company, today announced financial results for the full year 2018 and provided a corporate update.
"2018 was a year of rapid evolution toward our goal of becoming a fully integrated global biopharma company," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "We became a commercial-stage company with the marketing approvals and launches of ZEJULA and Optune in Hong Kong. In China, niraparib's NDA submission was accepted more than one year ahead of anticipated timeline, and was granted priority review status by the NMPA. We are very excited to prepare for a potential launch as anticipated in the second half of 2019. Pending the outcome of our clinical trial waiver request with the NMPA, Optune could also be launched in China this year."
"Our assets have demonstrated significant momentum both from advances in our clinical trials in China, which are highlighted below, as well as clinical developments announced by our partners, most recently by MacroGenics for the positive results from their pivotal SOPHIA study. Our broad, late stage pipeline has been carefully constructed to address significant unmet medical needs through products with first-in-class and/or best-in-class profile. We are also building a discovery pipeline that we believe will be synergistic with our clinical portfolio, and we expect to announce one to two IND filings per year starting next year."
Recent Pipeline and Product Highlights
MacroGenics exclusive collaboration and license agreement
FPA 144 (bemarituzumab)
ZL-2401 (omadacycline)
Recent Corporate Developments
Anticipated 2019 Milestones
ZL-2401 (omadacycline)
Full Year 2018 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, March 7, 2019 at 8:30 a.m. EST to review its financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of Zai Lab's website at http://ir.zailaboratory.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 866-394-4355 (U.S.); 314-888-4344 (International); 800966253 (Hong Kong) or 4006828609 (China) to listen to the live conference call. The conference ID number for the live call is 6980867. A replay of the webcast will be available for on Zai Lab's website for two weeks following the live conference call. The conference ID for the replay is 6980867.
Zai Lab routinely posts important information for investors on the Investor Relations section of its website, www.zailaboratory.com, as a means of disclosing material non-public information. Accordingly, investors should monitor the Investor Relations section of Zai Lab's website in addition to following Zai Lab's press releases, SEC filings and public conference calls and webcasts. The information contained on, or that may be accessed through, Zai Lab's website is not incorporated by reference into, and is not part of, this document.
Zai Lab (NASDAQ: ZLAB) is a China and US-based innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China's pharmaceutical market and addressing unmet medical needs. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners' and its own products in order to impact human health worldwide.
Zai Lab Forward-Looking Statements
This press release includes certain disclosures which contain "forward-looking statements," including, without limitation, statements regarding the timing of the initiation, progress and scope of the clinical trials of ZL-2306, FPA 144, ZL-2301, ZL-2401 and ETX2514, the commercial plans for ZL-2306 and Optune, the timing of results from clinical studies of our product candidates, the ability to obtain regulatory approval for Zai Lab's product candidates. You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on Zai Lab's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2017 and its other filings with the Securities and Exchange Commission. Zai Lab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Media: Nancie Steinberg / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
Investors: Jill Steier
Burns McClellan, on behalf of Zai Lab
212-213-0006, ext. 367, jsteier@burnsmc.com
Consolidated balance sheets
(In U.S. dollars ("$") except for number of shares)
| As of December 31, | ||||||||
| 2017 | 2018 | |||||||
| $ | $ | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | 229,660,148 | 62,951,607 | ||||||
| Short-term investments | - | 200,350,000 | ||||||
| Accounts receivable | - | 89,708 | ||||||
| Inventories | - | 3,822 | ||||||
| Prepayments and other current assets | 954,506 | 5,749,260 | ||||||
| Total current assets | 230,614,654 | 269,144,397 | ||||||
| Investments in equity investees | 1,650,348 | 3,149,855 | ||||||
| Prepayments for equipment | 126,411 | 275,853 | ||||||
| Property and equipment | 11,853,764 | 20,494,482 | ||||||
| Intangible assets | 20,089 | 321,566 | ||||||
| Long term deposits | 306,825 | 556,738 | ||||||
| Value added tax recoverable | 5,062,137 | 8,044,258 | ||||||
| Total assets | 249,634,228 | 301,987,149 | ||||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Short-term borrowings | - | 3,642,616 | ||||||
| Accounts payable | 8,967,685 | 37,432,035 | ||||||
| Other payables | 3,101,459 | 7,766,843 | ||||||
| Total current liabilities | 12,069,144 | 48,841,494 | ||||||
| Deferred income | 2,394,124 | 2,063,942 | ||||||
| Total liabilities | 14,463,268 | 50,905,436 | ||||||
| Shareholders' equity | ||||||||
| Ordinary shares | 2,995 | 3,481 | ||||||
| Subscription receivable | (18 | ) | - | |||||
| Additional paid-in capital | 345,269,688 | 498,043,011 | ||||||
| Accumulated deficit | (110,551,613 | ) | (249,626,508 | ) | ||||
| Accumulated other comprehensive income | 449,908 | 2,661,729 | ||||||
| Total shareholders' equity | 235,170,960 | 251,081,713 | ||||||
| Total liabilities and shareholders' equity | 249,634,228 | 301,987,149 |
Consolidated statements of operations
(In U.S. dollars ("$") except for number of shares)
| Year ended December 31, | |||||||||
| 2017 | 2018 | ||||||||
| $ | $ | ||||||||
| Revenue | - | 129,452 | |||||||
| Cost of sales | - | (43,590 | ) | ||||||
| Gross profit | - | 85,862 | |||||||
| Operating expenses: | |||||||||
| Research and development | (39,341,518 | ) | (120,278,023 | ) | |||||
| Selling, general and administrative | (12,049,518 | ) | (21,575,921 | ) | |||||
| Loss from operations | (51,391,036 | ) | (141,768,082 | ) | |||||
| Interest income | 527,351 | 3,260,634 | |||||||
| Interest expense | - | (39,672 | ) | ||||||
| Changes in fair value of warrants | 200,000 | - | |||||||
| Other income | 933,158 | 1,968,325 | |||||||
| Other expense | (403,997 | ) | (1,909,549 | ) | |||||
| Loss before income tax and share of loss from equity method investment | (50,134,524 | ) | (138,488,344 | ) | |||||
| Income tax expense | - | - | |||||||
| Share of loss from equity method investment | (249,652 | ) | (586,551 | ) | |||||
| Net loss | (50,384,176 | ) | (139,074,895 | ) | |||||
| Net loss attributable to ordinary shareholders | (50,384,176 | ) | (139,074,895 | ) | |||||
| Loss per share - basic and diluted | (2.32 | ) | (2.64 | ) | |||||
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 21,752,757 | 52,609,810 |
Consolidated statements of comprehensive loss
(In U.S. dollars ("$") except for number of shares)
| Year ended December 31, | ||||||||
| 2017 | 2018 | |||||||
| $ | $ | |||||||
| Net loss | (50,384,176 | ) | (139,074,895 | ) | ||||
| Other comprehensive income, net of tax of nil: | ||||||||
| Foreign currency translation adjustments | 1,148,440 | 2,211,821 | ||||||
| Comprehensive loss | (49,235,736 | ) | (136,863,074 | ) |