Full Press Release Details
Zai Lab Announces Financial Results for Six Months Ended June 30, 2020 and Corporate Updates
-- Company to Host Conference Call and Webcast Today at 8:00 a.m. EDT --
-- Recent highlights include successful ZEJULA and Optune commercial launches, NMPA approval for Optune, two highly strategic collaboration deals and three NDAs accepted with priority review --
SHANGHAI and SAN FRANCISCO, August 13, 2020 -- Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial-stage biopharmaceutical company, today announced financial results for the six months ended June 30, 2020 and corporate updates.
"This year we have continued to build Zai Lab's leadership through strong execution. Highlights include two successful commercial launches in China, NMPA approval for Optune, two highly strategic collaboration deals, three NDAs accepted with priority review, 15 clinical trial authorizations approved and eight trial initiations across our innovative pipeline which now includes 14 clinical stage assets," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "We were able to overcome headwinds brought on by the COVID-19 pandemic, launching both ZEJULA and Optune in under six weeks from regulatory approval and gaining immediate support from the medical, patient and payor communities. Our clinical pipeline continues to strengthen with the addition of two key late-stage assets, REGN1979 and Repotrectinib. With our broad and differentiated pipeline, we remain confident that Zai Lab can become a leading global biopharma company, leveraging our capabilities and network to drive the next wave of innovations with transformative impact on patients with significant unmet medical needs. Over the next three years, we expect to have a steady stream of approvals and commercial product launches in Greater China across multiple therapeutic areas, establish transformative partnerships, expand our global footprint, and advance our internally discovered global pipeline into the pivotal stage."
Key Product Highlights and Near Term Milestones
ZEJULA is an oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. It is the only once-daily PARP inhibitor approved in the US as monotherapy for all-comer patients in the first-line and recurrent maintenance treatment settings.
Near-term Milestones
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 cell death.
Near-term Milestones
Ripretinib is a KIT and PDGFR kinase switch control inhibitor for the treatment of KIT and/or PDGFR -driven cancers, including gastrointestinal stromal tumors (GIST), systemic mastocytosis, and other cancers. It is the only therapeutic approved in the US for advanced GIST patients who have received three or more lines of treatment in the all-comer setting.
Near-term Milestones
Odronextamab (REGN1979)
Odronextamab is an investigational bispecific monoclonal antibody that is designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Near-term Milestones
Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C with potential to treat TKI-na ve or TKI-pretreated patients.
Near-term Milestones
Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Near-term Milestones
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 is a beta-lactamase inhibitor which, in combination with sulbactam, provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains (CRAB).
Internal Programs with Global Rights
ZL-1201 is a humanized, IgG4 monoclonal antibody engineered to reduce effector function, that specifically targets CD47. Its therapeutic potential will be assessed in both solid tumors and hematological malignancies, in both mono and combination opportunities.
ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).
Other Upcoming Milestones
Tebotelimab (MGD013) - a first-in-class, bispecific PD-1 x LAG-3 DART molecule.
Retifanlimab - an anti-PD-1 monoclonal antibody.
Bemarituzumab - a first-in-class antibody for tumors that overexpress FGFR2b.
Business Development
First-Half 2020 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, August 13, 2020 at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows:
Registration Link: http://apac.directeventreg.com/registration/event/7077004
Conference ID: 7077004
All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.
A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://ir.zailaboratory.com.
Zai Lab (NASDAQ:ZLAB) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China's pharmaceutical market and address unmet medical needs, Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.
For additional information about the Company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
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 generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, 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 thousands of U.S. dollars ("$") except for number of shares)
| As of | ||||||||
| December 31, 2019 | June 30, 2020 | |||||||
| $ | $ | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | 75,932 | 258,604 | ||||||
| Short-term investments | 200,000 | 205,000 | ||||||
| Accounts receivable (net of allowance of nil and $2 as of December 31, 2019 and June 30, 2020, respectively) | 3,791 | 7,024 | ||||||
| Inventories, net | 6,005 | 6,569 | ||||||
| Prepayments and other current assets | 6,736 | 7,684 | ||||||
| Total current assets | 292,464 | 484,881 | ||||||
| Restricted cash, non-current | 510 | 510 | ||||||
| Investments in equity investees | 2,398 | 1,991 | ||||||
| Prepayments for equipment | 440 | 383 | ||||||
| Property and equipment, net | 21,353 | 21,017 | ||||||
| Operating lease right-of-use assets | 15,071 | 13,929 | ||||||
| Land use rights | 7,655 | 7,416 | ||||||
| Intangible assets, net | 1,148 | 1,216 | ||||||
| Long term deposits | 377 | 712 | ||||||
| Value added tax recoverable | 13,737 | 16,159 | ||||||
| Total assets | 355,153 | 548,214 | ||||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Short-term borrowings | 6,450 | 4,238 | ||||||
| Accounts payable | 22,660 | 32,392 | ||||||
| Current operating lease liabilities | 4,351 | 4,175 | ||||||
| Other current liabilities | 13,174 | 15,750 | ||||||
| Total current liabilities | 46,635 | 56,555 | ||||||
| Deferred income | 2,881 | 15,736 | ||||||
| Non-current operating lease liabilities | 10,977 | 10,457 | ||||||
| Total liabilities | 60,493 | 82,748 | ||||||
| Shareholders' equity | ||||||||
| Ordinary shares (par value of US$0.00006 per share; 83,333,333 shares authorized, 68,237,247 and 74,882,338 shares issued and outstanding as of December 31, 2019 and June 30, 2020, respectively) | 4 | 4 | ||||||
| Additional paid-in capital | 734,734 | 1,031,791 | ||||||
| Accumulated deficit | (444,698 | ) | (573,315 | ) | ||||
| Accumulated other comprehensive income | 4,620 | 6,986 | ||||||
| Total shareholders' equity | 294,660 | 465,466 | ||||||
| Total liabilities and shareholders' equity | 355,153 | 548,214 |
Unaudited condensed consolidated statements of operations
(In thousands of U.S. dollars ("$") except for number of shares and per share data)
| For the six months ended June 30, | ||||||||
| 2019 | 2020 | |||||||
| $ | $ | |||||||
| Revenue | 3,420 | 19,213 | ||||||
| Expenses: | ||||||||
| Cost of sales | (882 | ) | (4,980 | ) | ||||
| Research and development | (58,928 | ) | (102,049 | ) | ||||
| Selling, general and administrative | (29,489 | ) | (42,472 | ) | ||||
| Loss from operations | (85,879 | ) | (130,288 | ) | ||||
| Interest income | 3,365 | 2,882 | ||||||
| Interest expense | (137 | ) | (114 | ) | ||||
| Other expense, net | (307 | ) | (691 | ) | ||||
| Loss before income tax and share of loss from equity method investment | (82,958 | ) | (128,211 | ) | ||||
| Income tax expense | - | - | ||||||
| Share of loss from equity method investment | (316 | ) | (406 | ) | ||||
| Net loss | (83,274 | ) | (128,617 | ) | ||||
| Net loss attributable to ordinary shareholders | (83,274 | ) | (128,617 | ) | ||||
| Loss per share - basic and diluted | (1.37 | ) | (1.74 | ) | ||||
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 60,919,842 | 73,847,551 |
Unaudited condensed consolidated statements of comprehensive loss
(In thousands of U.S. dollars ("$"))
| For the six months ended June 30, | ||||||||
| 2019 | 2020 | |||||||
| $ | $ | |||||||
| Net loss | (83,274 | ) | (128,617 | ) | ||||
| Other comprehensive income, net of tax of nil: | ||||||||
| Foreign currency translation adjustments | 563 | 2,366 | ||||||
| Comprehensive loss | (82,711 | ) | (126,251 | ) |