Full Press Release Details
Zai Lab Announces Financial Results for Full Year Ended December 31, 2019 and Corporate Updates
-- Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT
SHANGHAI, China, and SAN FRANCISCO, March 19, 2020 -- Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced financial results for the twelve months ended December 31, 2019 and corporate updates.
"Coinciding with the celebration of our five-year anniversary, 2019 was a year of many important achievements for Zai Lab," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "Some key milestones achieved include the marketing approval obtained for ZEJULA in China and our submissions for regulatory approval in China for Optune and omadacyline in China. We also entered into licensing collaborations with Deciphera and Incyte, expanded our commercial platform in China, launched commercial activities for ZEJULA and Optune in Hong Kong and further enhanced our in-house R&D capabilities. We are proud of our global reputation as a biotech pioneer and a partner-of-choice in China, and we continued to deliver exceptional execution across global and local clinical development, regulatory affairs, business development and operational expansion. Despite the challenges caused by the coronavirus (COVID-19) in China and globally, we expect 2020 to be another pivotal year for us as we continue to advance our clinical pipeline and further demonstrate our commercial and discovery capabilities. The proceeds from our recent financing positions us well to execute our key strategic initiatives towards becoming a leading global biopharma company."
Key Product Highlights and Expected Milestones
ZEJULA is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor.
Tumor Treating Fields
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die.
Ripretinib is an investigational KIT and PDGFR kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFR -driven cancers, including gastrointestinal stromal tumors (GIST), systemic mastocytosis, and other cancers.
Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
NUZYRA (Omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Durlobactam (ETX2514)
Durlobactam is a beta-lactamase inhibitor which - in combination with sulbactam - provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains (CRAB).
Other Upcoming Milestones
MGD013 - a first-in-class, bispecific PD-1 x LAG-3 DART molecule
INCMGA0012 - an anti-PD-1 monoclonal antibody
FPA144 - a first-in-class antibody for tumors that overexpress FGFR2b
Business Development
Corporate Highlights
Full-Year 2019 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, March 19, 2020 at 8:30 a.m. EDT to review its financial results and provide a general business update.
The live webcast and a replay may be accessed by visiting the Company's website at http://ir.zailaboratory.com. Alternatively, please call (866) 5194004 (U.S.), +65 67135090 (International), 4006208038 (China), +852 30186771 (Hong Kong), or +44 2036214779 (United Kingdom) to listen to the live conference call. The conference ID number for the live call is 8093543. Telephone replay will be available shortly after the call. To access the replay, please call (855) 4525696 (U.S.). The conference ID number for the replay is 8093543.
Zai Lab (NASDAQ: ZLAB) is a China and U.S.-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 contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding our ability to advance our clinical pipeline and further demonstrate our commercial and discovery capabilities, expected milestones for our products and product candidates and other statements containing words such as "anticipates", "believes", "expects", "plan" and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent
uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to obtain additional future funding, (2) Zai Lab's results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's drug candidates, (4) Zai Lab's ability to commercialize and generate revenue from its drug candidates, and (5) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2018 and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and 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. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.
For more information, please contact:
Media: Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
212-213-0006 ext. 315 / 364
Investors: Pete Rahmer / Mike Zanoni
Endurance Advisors, on behalf of Zai Lab
415-515-9763 / 610-442-8570
Unaudited condensed consolidated balance sheets
(In U.S. dollars ("$") except for number of shares)
| As of December 31, | |||||||||
| 2018 | 2019 | ||||||||
| $ | $ | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | 62,951,607 | 75,932,037 | |||||||
| Short-term investments | 200,350,000 | 200,000,000 | |||||||
| Accounts receivable | 89,708 | 3,791,407 | |||||||
| Inventories | 3,822 | 6,004,932 | |||||||
| Prepayments and other current assets | 5,749,260 | 6,735,917 | |||||||
| Total current assets | 269,144,397 | 292,464,293 | |||||||
| Restricted cash, non-current | - | 510,218 | |||||||
| Investments in equity investees | 3,149,855 | 2,397,655 | |||||||
| Prepayments for equipment | 275,853 | 439,604 | |||||||
| Property and equipment, net | 20,494,482 | 21,353,437 | |||||||
| Operating lease right-of-use assets | - | 15,071,292 | |||||||
| Land use rights | - | 7,655,115 | |||||||
| Intangible assets, net | 321,566 | 1,147,797 | |||||||
| Long term deposits | 556,738 | 377,128 | |||||||
| Value added tax recoverable | 8,044,258 | 13,736,949 | |||||||
| Total assets | 301,987,149 | 355,153,488 | |||||||
| Liabilities and shareholders' equity | |||||||||
| Current liabilities: | |||||||||
| Short-term borrowings | 3,642,616 | 6,450,503 | |||||||
| Accounts payable | 37,432,035 | 22,659,600 | |||||||
| Current operating lease liabilities | - | 4,350,765 | |||||||
| Other current liabilities | 7,766,843 | 13,174,389 | |||||||
| Total current liabilities | 48,841,494 | 46,635,257 | |||||||
| Deferred income | 2,063,942 | 2,881,351 | |||||||
| Non-current operating lease liabilities | - | 10,976,846 | |||||||
| Total liabilities | 50,905,436 | 60,493,454 | |||||||
| Shareholders' equity | |||||||||
| Ordinary shares (par value of US$0.00006 per share; 83,333,333 shares authorized, 58,006,967 and 68,237,247 shares issued and outstanding as of December 31,2018 and 2019, respectively) | 3,481 | 4,094 | |||||||
| Additional paid-in capital | 498,043,011 | 734,733,914 | |||||||
| Accumulated deficit | (249,626,508 | ) | (444,697,632 | ) | |||||
| Accumulated other comprehensive income | 2,661,729 | 4,619,658 | |||||||
| Total shareholders' equity | 251,081,713 | 294,660,034 | |||||||
| Total liabilities and shareholders' equity | 301,987,149 | 355,153,488 |
Unaudited condensed consolidated statements of operations
(In U.S. dollars ("$") except for number of shares)
| For the year ended December 31, | |||||||||
| 2018 | 2019 | ||||||||
| $ | $ | ||||||||
| Revenue | 129,452 | 12,984,751 | |||||||
| Cost of sales | (43,590 | ) | (3,748,806 | ) | |||||
| Gross profit | 85,862 | 9,235,945 | |||||||
| Operating expenses: | |||||||||
| Research and development | (120,278,023 | ) | (142,221,056 | ) | |||||
| Selling, general and administrative | (21,575,921 | ) | (70,210,828 | ) | |||||
| Loss from operations | (141,768,082 | ) | (203,195,939 | ) | |||||
| Interest income, net | 3,220,962 | 7,939,230 | |||||||
| Other income, net | 58,776 | 937,785 | |||||||
| Loss before income tax and share of loss from equity method investment | (138,488,344 | ) | (194,318,924 | ) | |||||
| Income tax expense | - | - | |||||||
| Share of loss from equity method investment | (586,551 | ) | (752,200 | ) | |||||
| Net loss | (139,074,895 | ) | (195,071,124 | ) | |||||
| Net loss attributable to ordinary shareholders | (139,074,895 | ) | (195,071,124 | ) | |||||
| Loss per share - basic and diluted | (2.64 | ) | (3.03 | ) | |||||
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 52,609,810 | 64,369,490 |
Unaudited condensed consolidated statements of comprehensive loss
(In U.S. dollars ("$") except for number of shares)
| For the year ended December 31, | ||||||||
| 2018 | 2019 | |||||||
| $ | $ | |||||||
| Net loss | (139,074,895 | ) | (195,071,124 | ) | ||||
| Other comprehensive income, net of tax of nil: | ||||||||
| Foreign currency translation adjustments | 2,211,821 | 1,957,929 | ||||||
| Comprehensive loss | (136,863,074 | ) | (193,113,195 | ) |