Full Press Release Details
Zai Lab Announces Financial Results and Corporate Update for the Six Months Ended June 30, 2019
-- Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT--
SHANGHAI, China and SAN FRANCISCO, Sep. 3, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited ("Zai Lab" or "the Company") (NASDAQ: ZLAB), a China and U.S.-based innovative commercial-stage biopharmaceutical company, today announced financial results for the six months ended June 30, 2019 and provided a corporate update.
"During the first half of 2019 we continued to make significant progress toward our objective of becoming a fully integrated global biopharmaceutical company. Our portfolio currently includes ten clinical assets, nine of which are in late stage, targeting over 20 indications," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "We launched our two lead oncology products, ZEJULA and Optune in Hong Kong and ZEJULA in Macau. We submitted applications for marketing approval in China for both of these therapeutics and have built a full commercial platform. Other late-stage product candidates, such as margetuximab, ripretinib, bemarituzumab, omadacycline and sulbactam-durlobactam, continue to advance in clinical development and hit significant milestones through efforts by Zai Lab and our strategic partners. As always, we constantly search for novel and potentially best-in-class clinical candidates that would both complement our pipeline across key indications and address unmet medical needs in Greater China. So far this year, we entered into two collaborative agreements, one with Deciphera on an advanced clinical-stage gastrointestinal cancer drug candidate ripretinib and the other with Incyte on a potential globally competitive anti-PD-1 antibody, INCMGA0012, which may be combined with several of our other oncology candidates. With a growing pipeline and execution progress, Zai Lab has established a global reputation as a China biotech pioneer. Zai Lab is already an integrated biopharma with nearly 600 employees across six offices in Greater China and the U.S. With proven global and local clinical development, regulatory and business development expertise, we also look forward to demonstrating our commercial and discovery capabilities in the near future. The proceeds from our recent financing positions us to execute on all of our top initiatives as we continue to build and expand our business. We expect the upcoming months to potentially be transformative for Zai Lab as we prepare for the marketing approvals for ZEJULA and Optune in China."
Recent Pipeline and Product Highlights
ZEJULA (niraparib), a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor.
Optune , a Tumor Treating Fields delivery system that uses electric fields tuned to specific frequencies to disrupt cancer cell division, inhibiting tumor growth and causing affected cancer cells to die.
Margetuximab, an investigational, Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2).
Ripretinib, 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.
INCMGA0012, an investigational mAb that inhibits PD-1, currently being evaluated as a monotherapy in registrational trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.
Bemarituzumab, a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b.
NUZYRA (Omadacycline), 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).
Sulbactam-durlobactam, a novel, broad-spectrum and potent inhibitor of Class A, C, and D -lactamases. This is a novel IV antibiotic for the treatment of infections caused by carbapenem-resistant Acinetobacter.
Recent Corporate Developments
Anticipated Upcoming Milestones
Sulbactam-durlobactam
First Half 2019 Financial Results
Since the Hong Kong launch of ZEJULA in October 2018, it has rapidly gained market share in the region despite being launched more than two years behind LYNPARZA. Based on IQVIA* (formerly IMS) data, ZEJULA is now the market leading PARP inhibitor with market share in Hong Kong of 66% in the second quarter of 2019.
Officially launched in February 2019, Optune's revenue has ramped ahead of expectations, with strong momentum generated for the second half of the year.
* IQVIA Hong Kong Pharmaceutical Audit QTR 2Q2019 data
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, September 3, 2019 at 8:30 a.m. EDT 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) 519-4004 (U.S.); +65 67135090 (International); +852 30186771 (Hong Kong); 4006208038 (China) to listen to the live conference call. The conference ID number for the live call is 6785308. 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 6785308.
Zai Lab (NASDAQ: ZLAB) is a Shanghai-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 our product candidates, the timing of commercial launch of ZEJULA and Optune in China, the timing of results from clinical studies of our product candidates and 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, 2018 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: Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
Burns McClellan, on behalf of Zai Lab
212-213-0006, ext. 331, lroth@burnsmc.com
Condensed consolidated balance sheets (U.S. GAAP)
(In U.S. dollars ("$") except for number of shares)
| As of June 30, | As of December 31, | ||||||||
| 2019 | 2018 | ||||||||
| $ | $ | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | 91,602,489 | 62,951,607 | |||||||
| Short-term investments | 301,600,000 | 200,350,000 | |||||||
| Accounts receivable | 2,483,131 | 89,708 | |||||||
| Inventories | 141,103 | 3,822 | |||||||
| Prepayments and other current assets | 5,971,200 | 5,749,260 | |||||||
| Total current assets | 401,797,923 | 269,144,397 | |||||||
| Investments in equity investees | 2,833,568 | 3,149,855 | |||||||
| Prepayments for equipment | - | 275,853 | |||||||
| Property and equipment | 21,906,317 | 20,494,482 | |||||||
| Operating lease right-of-use assets | 7,698,765 | - | |||||||
| Intangible assets | 663,667 | 321,566 | |||||||
| Long-term deposits | 389,773 | 556,738 | |||||||
| Value added tax recoverable | 11,170,490 | 8,044,258 | |||||||
| Total assets | 446,460,503 | 301,987,149 | |||||||
| Liabilities and shareholders' equity | |||||||||
| Current liabilities: | |||||||||
| Short-term borrowing | 5,818,436 | 3,642,616 | |||||||
| Accounts payable | 27,725,527 | 37,432,035 | |||||||
| Current operating lease liabilities | 2,899,075 | - | |||||||
| Other payables | 9,526,288 | 7,766,843 | |||||||
| Total current liabilities | 45,969,326 | 48,841,494 | |||||||
| Deferred income | 2,514,473 | 2,063,942 | |||||||
| Non-current operating lease liabilities | 4,646,586 | - | |||||||
| Total liabilities | 53,130,385 | 50,905,436 | |||||||
| Total shareholders' equity | 393,330,118 | 251,081,713 | |||||||
| Total liabilities and shareholders' equity | 446,460,503 | 301,987,149 |
Condensed consolidated statements of operations (U.S. GAAP)
(In U.S. dollars ("$") except for number of shares)
| For the six months ended June 30, | |||||||||
| 2019 | 2018 | ||||||||
| $ | $ | ||||||||
| Revenue | 3,420,183 | - | |||||||
| Cost of sales | (881,774 | ) | - | ||||||
| Gross profit | 2,538,409 | - | |||||||
| Operating expenses: | |||||||||
| Research and development | (58,928,465 | ) | (34,632,256 | ) | |||||
| Selling, general and administrative | (29,488,857 | ) | (6,364,088 | ) | |||||
| Loss from operations | (85,878,913 | ) | (40,996,344 | ) | |||||
| Interest income | 3,505,043 | 407,977 | |||||||
| Interest expense | (276,768 | ) | - | ||||||
| Other expenses, net | (320,258 | ) | (695,618 | ) | |||||
| Loss before income tax and share of loss from equity method investment | (82,970,896 | ) | (41,283,985 | ) | |||||
| Income tax expense | - | - | |||||||
| Share of loss from equity method investment | (302,827 | ) | (206,443 | ) | |||||
| Net loss | (83,273,723 | ) | (41,490,428 | ) | |||||
| Net loss attributable to ordinary shareholders | (83,273,723 | ) | (41,490,428 | ) | |||||
| Loss per share - basic and diluted | (1.37 | ) | (0.83 | ) | |||||
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 60,919,842 | 50,041,672 |
Condensed consolidated statements of comprehensive loss (U.S. GAAP)
(In U.S. dollars ("$") except for number of shares)
| For the six months ended June 30, | |||||||||
| 2019 | 2018 | ||||||||
| $ | $ | ||||||||
| Net loss | (83,273,723 | ) | (41,490,428 | ) | |||||
| Other comprehensive income, net of tax of nil: | |||||||||
| Foreign currency translation adjustments | 563,065 | 418,389 | |||||||
| Comprehensive loss | (82,710,658 | ) | (41,072,039 | ) |