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- Encouraging results of 1st interim analysis of the Oraxol Phase III clinical trial for breast cancer
- Commencement of the KX-01 ointment Phase III clinical trials for Actinic Keratosis
- Launched Oxaliplatin Injection, Terbutaline Sulfate Injection, and Ketorolac Tromethamine Injection in the Athenex Pharmaceutical Division, further expanding the APD product portfolio
- Revenue of
$14 millionfor the third quarter 2017, up 149% year-over-year
- Company raises full-year revenue guidance to the range of
$33 million - $35 million
“We are pleased to report a strong third quarter, advancing our lead candidates through Phase III clinical trials in our Orascovery and Src Kinase platforms, as well as delivering healthy revenue through our commercial platform,” stated
Dr. Lau continued, “These aforementioned achievements underscore the capabilities of our clinical development platforms, which are the primary focuses of
Third Quarter 2017 and Recent Business Highlights:
- An independent Drug Safety Monitoring Board (DSMB) reviewed the clinical efficacy and safety of 90 patients in the Oraxol Phase III Clinical Trial for breast cancer in a pre-planned 1st interim analysis in
September 2017. The DSMB was impressed by the good response rates and very low incidence of neuropathy as compared to IV paclitaxel control. The DSMB unanimously recommended continuation and the rapid patient recruitment for this study.
• Src Kinase Inhibition
- KX-01 ointment Phase II clinical trial showed excellent efficacy with a dramatic decrease in the frequency of severe local skin reactions compared with published data of the current standard of topical therapy for actinic keratosis. After consultation with the
FDA, two Phase III randomized double-blind controlled clinical trials of KX-01 ointment for Actinic Keratosis are commenced in USA.
• Launched Oxaliplatin Injection, Terbutaline Sulfate injection, and Ketorolac Tromethamine Injection.
• Athenex Pharmaceutical Division (“APD”) currently markets 14 products in the U.S. with 24 SKUs.
• Athenex Pharma Solutions (“APS”), our 503(b) outsourced facility, currently markets 5 products with 14 SKUs.
• Entered Grant Disbursement Agreement with
Third Quarter and Year to Date 2017 Financial Results:
Revenue for the three months ended
Revenue for the nine months ended
Cash, cash equivalents and short-term investments were
Cash used in operations for the nine months ended
Research and development (R&D) expenses for the three months ended
R&D expenses for the nine months ended
Selling, General, and Administrative expenses for the three months ended
SG&A expenses for the nine months ended
Outlook and Upcoming Milestones:
• Paclitaxel is one of the most commonly used and effective anti-cancer drugs worldwide. Neuropathy is a severe dose limiting side-effect of IV paclitaxel. If the superior clinical efficacy and the very low rate of neuropathy of Oraxol versus IV paclitaxel can be confirmed in this randomized controlled Phase III clinical trial, it may represent a breakthrough treatment for therapy of cancer. The pre-scheduled 2nd interim analysis of this Oraxol Phase III clinical trial at 180 patients is expected to be in 2018.
• Actinic keratosis is a common skin condition affecting more than 50 million people in
• Data release for the positive results of KX-01 Phase II clinical trial in actinic keratosis is expected in 4Q 2017.
• Completion of patient recruitment for the two KX-01 Phase III clinical trials totaling 600 patients is expected to be in eight months.
• Increased expectations for full-year revenue in the range of
• Anticipate the launch of four additional products in Athenex Pharmaceutical Division and two products in Athenex Pharma Solutions in 4Q’17.
• Groundbreaking on
Conference Call and Webcast Information:
The Company will host a conference call and audio webcast on Thursday, November 9, 2017 at 9:00 a.m. Eastern Time. To participate in the call, dial (855) 227-0567 (domestic) or (612) 979-9912 (international) fifteen minutes before the conference call begins and reference the conference passcode 4869599. A replay will be available approximately one hour after the recording through Thursday, November 16, 2017 and can be accessed by dialing (855) 859-2056. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until December 9, 2017.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athene believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing,
Forward-Looking Statement Disclaimer/Safe Harbor Statement
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our need to raise additional capital; competition; intellectual property risks; risks relating to doing business in
|Three Months Ended September 30,|
|(in thousands)||(in thousands)||(in thousands)||%|
|Cost of product sales||(8,082||)||(5,416||)||$||(2,666||)||49||%|
|Research and development expenses||(11,944||)||(18,052||)||$||6,108||-34||%|
|Selling, general, and administrative expenses||(10,364||)||(6,790||)||$||(3,574||)||53||%|
|Unrealized loss on derivative liability||(6,548||)||-||$||(6,548||)||NM|
|Income tax (expense) benefit||(11||)||(9||)||$||(2||)||22||%|
|Less: net loss attributable to non-controlling interests||(34||)||(34||)||-||0||%|
|Net loss attributable to Athenex, Inc.||$||(23,274||)||$||(24,622||)||$||1,348|
|Nine Months Ended September 30,|
|(in thousands)||(in thousands)||(in thousands)||%|
|Cost of product sales||(15,058||)||(14,392||)||$||(666||)||5||%|
|Research and development expenses||(55,949||)||(33,443||)||$||(22,506||)||67||%|
|Selling, general, and administrative expenses||(33,795||)||(15,694||)||$||(18,101||)||115||%|
|Unrealized loss on derivative liability||(15,411||)||-||$||(15,411||)||NM|
|Income tax benefit||52||294||$||(242||)||-82||%|
|Less: net loss attributable to non-controlling interests||(114||)||(144||)||30||-21||%|
|Net loss attributable to Athenex, Inc.||$||(102,887||)||$||(47,661||)||$||(55,226||)|
|September 30,||December 31,|
|Balance sheet data:||(in thousands)|
|Cash, cash equivalents and shot-term investments||$||69,043||$||41,753|
|Working capital *||63,176||23,904|
|Total stockholders' equity||$||114,900||$||34,669|
|*Working capital: total current assets - total current liabilities|
|Nine Months Ended September 30,|
|Cash flow summary:||(in thousands)|
|Net cash (used in) operating activities||$||(63,644||)||$||(35,166||)|
|Net cash (used in) investing activities||(47,022||)||(2,244||)|
|Net cash provided by financing activities||96,093||37,623|
|Net effect of foreign exchange rate changes||710||(177||)|
|Net increase (decrease) in cash and cash equivalents||$||(13,863||)||$||36|