|View printer-friendly version|BioTimeto receive $43 millionfrom Juvenescence BioTimeshareholders to receive one share of AgeX common stock for every 10 shares of BioTimecommon stock held BioTimeclinical programs including OpRegen® for dry-AMD and Renevia® for volume enhancement are on track
- Conference call and webcast today at
1:30pm PT/ 4:30pm ET
“BioTime’s execution in the second quarter demonstrates the strength of our strategy. Our focus on clinical progress has accelerated our product development of our core programs. With our non-core programs, we have, in fewer than two years, generated over
Second Quarter Highlights and Financial Results
BioTimeto receive $43.2 millionfrom Juvenescence. Under the terms of the agreement, Juvenescence will purchase, in a single transaction, 14.4 million shares of AgeX Therapeutics from BioTimefor $43.2 million. 50% of the purchase price will be paid to BioTimein cash and the remaining 50% will be a 2-year convertible/redeemable note with an annual interest rate of 7%, payable at maturity. If not converted into Juvenescence stock earlier upon an IPO, at maturity BioTimewill have the option of receiving its payment in cash or by converting the note and accrued interest into Juvenescence stock. BioTimeannounced the distribution ratio for the upcoming distribution of AgeX. BioTimeshareholders will receive one share of AgeX common stock for every 10 shares of BioTimecommon stock held.
- AgeX closed a $5 million equity financing, through the sale of two million AgeX common shares to Juvenescence.
BioTimeannounced the submission of the draft registration statement for the proposed distribution of AgeX. The record date of July 31, 2018for the distribution of AgeX was set by the BioTime Board of Directors. BioTimelicensed one of its pluripotent cell lines to Goliver Therapeutics, a France-based company focused on addressing liver diseases with regenerative technologies. BioTimecell lines are thoroughly characterized and NIH-registered. They include all necessary donor history and documentation.
Clinical Progress Highlights
Renevia® (Facial Lipoatrophy)
BioTimecontinued discussions with European regulatory authorities regarding Renevia’s® CE Mark in Europe. Expected Renevia® CE Mark approval remains Q4 2018.
- BioTime announced the start of an investigator-led study of Premvia™ designed and conducted by Dr.
Gordon H. Sasaki. The study will focus on safety and performance of Premvia™, in combination with the patient’s own fat, for the treatment of volume augmentation in the hands. Premvia™ is a medical device that has 510(k) clearance in the U.S. for wound management. It has the same components as Renevia®, BioTime’s investigational medical device that is being developed as an alternative for fat grafting procedures.
BioTimeinitiated enrollment and treatment of better vision patients in the fourth cohort of the OpRegen® clinical trial. OpRegen® has generally been well tolerated with no unexpected serious adverse events noted to date. Imaging analysis from patients may suggest positive signals of structural improvement in the retina, as we have previously seen in our animal models. BioTimesuccessfully transplanted OpRegen® in the final patient of the third cohort extension.
- BioTime’s subsidiary,
Cell Cure Neurosciences Ltd., was awarded a new grant for 2018 of approximately $1.9 million from the Israel Innovation Authority (IIA). The grant provides funding for the continued development of OpRegen®, and to date the IIA has provided annual grants totaling over $13 million. BioTimefurther expanded the OpRegen® clinical trial in dry-AMD with the opening of two additional U.S. sites: Byers Eye Instituteat Stanford University School of Medicine, Diana V. Do, MD, Professor of Ophthalmology. The Retinal Consultants Medical Groupserving northern California, David Telander, MD, PhD.
BioTimewas awarded a grant of approximately $0.7 Million from the Small Business Innovation Research (SBIR) program of the National Institutes of Health. This award constitutes the second-year funding of a $1.6 million SBIR grant to advance BioTime’s innovative, next generation retinal restoration program addressing advanced retinal diseases and injuries.
Second Quarter Financial Results
Value of Holdings in Public Affiliates: At June 30, 2018, BioTime held common stock in publicly-traded affiliates valued at approximately
Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenue was $2.5 million for the second quarter of 2018, compared to $0.4 million in the second quarter of 2017, an increase of
For the six months ended
Operating Expenses: Total operating expenses for the second quarter of 2018 were $11.6 million, as reported, which is comprised of
The reconciliation between GAAP and non-GAAP operating expenses by entity, is provided in the financial tables included with this earnings release.
R&D Expenses: Second quarter research and development expenses were $6.4 million compared to
G&A Expenses: Second quarter general and administrative expenses were $5.2 million compared to $4.4 million for the comparable period in 2017, an increase of
General and administrative expenses for the six months ended
Net Income or loss attributable to BioTime: Second quarter net loss attributable to
Conference Call and Webcast Details
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) procedures. Renevia® is part of the HyStem® hydrogel family of proprietary injectable matrices, being developed as devices for various applications and for cell and drug delivery.
OpRegen®, which is being studied for the treatment of the dry form of AMD, consists of a suspension of retinal pigment epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® will be administered in a single procedure. OpRegen® was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen® is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.
Premvia™ Important Information
- Premvia™ is indicated for the management of wounds including: partial-thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears, and draining wounds.
- Premvia™ is contraindicated for patients with severe allergies, indicated by a history of anaphylaxis or presence of multiple severe allergies.
- Premvia™ is specifically contraindicated for patients with known allergies to products containing either hyaluronan or collagen derivatives.
- Premvia™ is not indicated for use in third degree burns.
Important Safety Information
- Complications that may arise from wound management products may include: infection, chronic inflammation, allergic reaction, excessive redness, pain, or swelling. If any of these complications are present, product should be removed from the wound area.
- Federal law restricts this device to sale by or on the order of a physician or practitioner.
- Only the vial contents are sterile – outside of vials are not sterile.
- Do not add additional components or additives to Premvia™.
BioTime is a clinical-stage biotechnology company focused on degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is producing new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases or injuries. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery matrix technology. HyStem® was designed, in part, to provide for the transfer, retention and/or engraftment of cellular replacement therapies. BioTime’s lead cell delivery clinical program is Renevia®, which consists of HyStem® combined with the patient's own adipose (fat) progenitor cells. Renevia® met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017.
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn,
To receive ongoing BioTime corporate communications, please click on the following link to join the Company’s email alert list: BioTime Email Alerts.
About AgeX Therapeutics
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Investors are cautioned that statements in this press release regarding: (a) any value to BioTime shareholders of the AgeX common stock; (b) BioTime's plans or expectations for the distribution; and (c) potential listing of AgeX common stock on NYSE American, constitute forward-looking statements. Forward-looking statements involve risks and uncertainties. These risks and uncertainties, include, without limitation: (i) the possibility that BioTime shareholders may realize little or no value from the AgeX common stock; (ii) the potential inability of BioTime to complete distribution in a timely manner or at all, including as a result of the failure of BioTime and/or AgeX to obtain or maintain required federal and state registrations and qualifications necessary to enable the distribution, and related transactions; (iii) the possibility of litigation that could arise as a result of or in connection with the distribution and related transactions; and (iv) that there is no existing public market for AgeX common stock, nor may a public market for such securities ever develop. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of BioTime’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change.
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||27,207||$||36,838|
|Marketable equity securities||1,948||1,337|
|Trade accounts and other receivables, net||1,693||780|
|Receivable from affiliates, net||2,076||2,266|
|Prepaid expenses and other current assets||1,571||1,402|
|Total current assets||34,495||42,623|
|Property, plant and equipment, net||5,014||5,533|
|Deposits and other long-term assets||229||1,018|
|Equity method investment in OncoCyte, at fair value||37,419||68,235|
|Equity method investment in Asterias, at fair value||29,359||48,932|
|Intangible assets, net||5,735||6,900|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||5,028||$||5,718|
|Capital lease and lease liabilities, current portion||225||212|
|Promissory notes, current portion||120||152|
|Deferred license and subscription revenues||367||488|
|Deferred grant revenues||103||309|
|Total current liabilities||5,843||6,879|
|Deferred rent liabilities, net of current portion||189||105|
|Lease liability, net of current portion||915||1,019|
|Capital lease, net of current portion||116||132|
|Promissory notes, net of current portion||-||18|
|Liability classified warrants and other long-term liabilities||437||825|
|Commitments and contingencies|
|Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of June 30, 2018 and December 31, 2017||-||-|
|Common shares, no par value, 250,000 shares authorized; 126,873 shares issued and outstanding as of June 30, 2018 and 126,866 shares issued and outstanding as of December 31, 2017||383,529||378,487|
|Accumulated other comprehensive income||1,082||451|
|BioTime, Inc. shareholders’ equity||100,981||162,641|
|Total shareholders’ equity||104,751||164,263|
|TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY||$||112,251||$||173,241|
BIOTIME, INC. AND SUBSIDIARIES
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(IN THOUSANDS, EXCEPT PER SHARE DATA)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Royalties from product sales and license fees||91||81||227||191|
|Subscription and advertisement revenues||333||300||572||564|
|Sale of research products and services||182||-||182||5|
|Cost of sales||(106||)||(5||)||(215||)||(62||)|
|Research and development||(6,358||)||(6,271||)||(12,293||)||(12,765||)|
|Acquired in-process research and development||-||-||(800||)||-|
|General and administrative||(5,227||)||(4,423||)||(11,163||)||(9,524||)|
|Total operating expenses||(11,585||)||(10,694||)||(24,256||)||(22,289||)|
|Gain on sale of assets||-||1,754||-||1,754|
|Loss from operations||(9,144||)||(8,564||)||(21,224||)||(19,826||)|
|Interest income (expense), net||52||(413||)||105||(719||)|
|Gain on sale of equity method investment in Ascendance||-||-||3,215||-|
|Gain on deconsolidation of OncoCyte||-||-||-||71,697|
|Gain (loss) on equity method investment in OncoCyte at fair value||6,603||(11,006||)||(30,816||)||5,136|
|Gain (loss) on equity method investment in Asterias at fair value||(2,175||)||3,262||(19,573||)||(22,835||)|
|Unrealized gain on marketable equity securities||397||-||612||-|
|Other income (expense), net||(379||)||617||(663||)||1,344|
|Total other income (expense), net||4,498||(7,540||)||(47,120||)||54,623|
|INCOME (LOSS) BEFORE INCOME TAXES||(4,646||)||(16,104||)||(68,344||)||34,797|
|Deferred income tax benefit||-||3,877||-||-|
|NET INCOME (LOSS)||(4,646||)||(12,227||)||(68,344||)||34,797|
|Net loss attributable to noncontrolling interest||431||576||581||2,840|
|NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.||$||(4,215||)||$||(11,651||)||$||(67,763||)||$||37,637|
|NET INCOME (LOSS) PER COMMON SHARE:|
|WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:|
|BIOTIME, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS|
|Six Months Ended|
|CASH FLOWS FROM OPERATING ACTIVITIES:|
|Net income (loss) attributable to BioTime, Inc.||$||(67,763||)||$||37,637|
|Net loss allocable to noncontrolling interest||(581||)||(2,840||)|
|Adjustments to reconcile net income (loss) attributable to BioTime, Inc. to net cash used in operating activities:|
|Gain on deconsolidation of OncoCyte||-||(71,697||)|
|Gain on sale of equity method investment in Ascendance||(3,215||)||-|
|Acquired in-process research and development||800||-|
|Unrealized (gain) loss in equity investment in OncoCyte at fair value||30,816||(5,136||)|
|Unrealized loss on equity method investment in Asterias at fair value||19,573||22,835|
|Unrealized gain on marketable equity securities||(612||)||-|
|Depreciation expense, including amortization of leasehold improvements||560||421|
|Amortization of intangible assets||1,164||1,184|
|Change in fair value of warrant liability||(351||)||-|
|Amortization of discount on related party convertible debt||-||640|
|Foreign currency remeasurement and other (gain) loss||1,137||(1,814||)|
|Gain on sale of assets||-||(1,754||)|
|Changes in operating assets and liabilities:|
|Accounts and grants receivable, net||(868||)||299|
|Receivables from affiliates, net of payables||180||332|
|Prepaid expenses and other current assets||(259||)||105|
|Accounts payable and accrued liabilities||(336||)||841|
|Net cash used in operating activities||(17,738||)||(17,161||)|
|CASH FLOWS FROM INVESTING ACTIVITIES:|
|Deconsolidation of cash and cash equivalents of OncoCyte||-||(8,898||)|
|Proceeds from the sale of equity method investment in Ascendance||3,215||-|
|Purchase of in-process research and development||(800||)||-|
|Purchase of equipment and other assets||(237||)||(474||)|
|Security deposit and other||(8||)||(12||)|
|Net cash provided by (used in) investing activities||2,170||(9,384||)|
|CASH FLOWS FROM FINANCING ACTIVITIES:|
|Proceeds from issuance of common shares||-||20,125|
|Fees paid on sale of common shares||-||(1,669||)|
|Proceeds deposited in escrow account||-||5,100|
|Proceeds from exercises of stock options||-||29|
|Common shares received and retired for employee taxes paid||(13||)||(31||)|
|Proceeds from sale of common shares of subsidiary||5,000||-|
|Proceeds from sale of subsidiary warrants||737||-|
|Repayment of lease liability and capital lease obligation||(151||)||(31||)|
|Reimbursement from landlord on construction in progress||-||198|
|Proceeds from issuance of related party convertible debt||-||299|
|Payment to repurchase subsidiary shares||(38||)||-|
|Net cash provided by financing activities||5,535||24,020|
|Effect of exchange rate changes on cash, cash equivalents and restricted cash||(21||)||87|
|NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH||(10,054||)||(2,438||)|
|CASH, CASH EQUIVALENTS, AND RESTRICTED CASH:|
|At beginning of the period||37,685||22,935|
|At end of the period||$||27,631||$||20,497|
Non-GAAP Financial Measures
This press release includes operating expenses prepared in accordance with accounting principles generally accepted in
Furthermore, management uses these non-GAAP financial measures in the aggregate and on an entity basis to establish budgets and operational goals, to manage BioTime’s business and to evaluate its performance and its programs in clinical development.
BIOTIME, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP FINANCIAL MEASURE
ADJUSTED OPERATING EXPENSES
|Amounts In Thousands|
For the Three Months
For the Six Months Ended
|GAAP Operating Expenses - as reported||$||11,585||$||24,256|
|Stock-based and other noncash compensation expense (1)||(1,268||)||(2,587||)|
|Depreciation and amortization expense (1)||(861||)||(1,734||)|
|Acquired in-process research and development expense (2)||-||(800||)|
|Non-GAAP Operating Expenses, as adjusted||$||9,456||$||19,135|
|GAAP Operating Expenses - by entity|
|BioTime and subsidiaries other than AgeX Therapeutics, Inc.||$||9,131||$||18,121|
AgeX Therapeutics, Inc. and subsidiaries
|GAAP Operating Expenses - by entity||$||11,585||$||24,256|
|Non-GAAP Operating Expenses - as adjusted, by entity|
|BioTime and subsidiaries other than AgeX Therapeutics, Inc. (3)||$||7,323||$||14,518|
AgeX Therapeutics, Inc. and subsidiaries (4)
|Non-GAAP Operating Expenses - as adjusted, by entity||$||9,456||$||19,135|
|(2)||AgeX acquired certain in-process research and development as part of an asset acquisition from Ascendance, considered to be a nonrecurring item.|
|(3)||BioTime, Inc. includes Cell Cure Neurosciences Ltd., ES Cell International Pte. Ltd. and OrthoCyte Corporation. For the three and six months ended June 30, 2018, the GAAP and non-GAAP operating expenses do not include grant revenues of $1.9 million and $2.3 million, respectively, as grants are revenues for the Company.|
|(4)||AgeX Therapeutics, Inc. includes LifeMap Sciences Inc., LifeMap Sciences Ltd., and ReCyte Therapeutics, Inc.|
Investor and Media Contact:
David Nakasone, 510-871-4188