OvaScience Reports First Quarter 2016 Financial Results
— AUGMENT treatment gains traction in growing fertility market and Company expands access internationally —
— New research supports AUGMENT and pipeline treatments—
“OvaScience is currently focused on building our operational platform to
support the expansion of the AUGMENT treatment. We are focusing our
AUGMENT commercial efforts to target
First Quarter and Recent Highlights
AUGMENT Treatment: The AUGMENTSM treatment is designed to improve egg health by using mitochondria from a woman’s own egg precursor (EggPCSM) cells during in vitro fertilization (IVF). Improved egg health is essential for fertilization and embryo development.
Implementing deep and narrow commercial expansion
The Company is growing its business in
Canada. Clinics with which OvaSciencehas existing relationships are continuing to offer the AUGMENT treatment. Further, OvaSciencerecently entered into agreements under which two new Canadian clinics, CReATe Fertility Centre and NewLife Fertility Centre, will offer the AUGMENT treatment.
In addition, enrollment of the non-commercial preceptorship training program at IVF Japan is complete. The Company continues to make progress toward commercialization in
Advancing egg allocation study with the
IVI Group OvaScienceis currently working with the IVI Groupin Valencia, Spain, the largest IVF clinic network in the world. Enrollment of patients in an adaptive, controlled, double-blind, prospective and randomized egg allocation study to evaluate the success rates of the AUGMENT treatment compared to standard IVF is ongoing. The Company expects to announce data from the study in the second half of 2017.
Scientific data further validating the AUGMENT treatment
approach published in Scientific Reports
March 2016, data from a proof-of-concept study using a large animal model was published in a peer-reviewed article in Scientific Reports, a Nature journal. Results further validate the AUGMENT treatment’s mechanism of action and support the current body of evidence on the potential role of EggPC cell mitochondria to improve female fertility and rescue poor quality eggs.
Additional healthy babies born with the AUGMENT treatment
The Company is continuing to see success with the AUGMENT treatment. To date, 30 babies have been born using AUGMENT. The first baby born with the AUGMENT treatment recently celebrated his first birthday.
OvaPrimeSM Treatment: The OvaPrime treatment is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve. Poor egg reserve affects approximately 25% of those seeking fertility treatment. The OvaPrime treatment is designed to transfer a woman’s EggPC cells to her own ovary, where they may mature into fertilizable eggs during a standard IVF process. In preclinical studies, OvaPrime was shown to result in a mature, fertilizable egg.
Advanced OvaPrime clinical study
OvaScienceadvanced its study of the OvaPrime treatment outside the U.S. The study is designed to evaluate safety, changes in a patient’s hormone levels and follicular development as measured by ultrasound. The Company plans to provide an update on the path forward for OvaPrime by year-end.
OvaTureSM Treatment: The OvaTure treatment is a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing EggPC cells into eggs outside the body. It may be an option for women with compromised eggs, who are unable to make eggs or may be unwilling or unable to undergo hormone hyperstimulation.
Continued to advance process for the OvaTure treatment
OvaSciencecontinues to advance the OvaTure treatment and made progress in maturing and characterizing EggPC-derived eggs.
Ovarian Club VII,
May 21-22, in Hong Kong, China
- Abstract title:“Structural integrity and bioenergetics activity of human ovarian egg precursor cell (EggPC)-derived mitochondria are maintained by a novel cryopreservation approach.”
European Society of Human Reproduction and Embryology(ESHRE), July 3-6, in Helsinki, Finland
- Abstract title: “Preclinical data support the safety of egg precursor cell (EggPC) repositioning using a method designed to address poor response to controlled ovarian stimulation.”
Society for the Study of Reproduction(SSR), July 15-16, in San Diego, CA
- Abstract title: “Characterization of human oocytes using immunohistochemistry and polymerase chain reaction.”
- Abstract title: “Isolation and Characterization of a Human Monoclonal Antibody Against DEAD Box Protein 4 For Use in Isolating Human Egg Precursor Cells From Ovarian Tissue.”
The Company is focused on execution in 2016 and expects to achieve the following milestones by the end of the year:
- Continue commercial expansion of AUGMENT in key regions;
Progressenrollment in the egg allocation study with the IVI Group;
Prepare for commercialization of AUGMENT in
- Determine the path forward for OvaPrime by year-end.
First Quarter Financial Results
Revenue for the quarter ended
March 31, 2016was $146,000as compared to $15,000for the same period in 2015. The revenue recognized in the first quarter of 2016 relates to 24 AUGMENT cycles, including treatments offered under various pricing programs. These pricing programs are designed to broaden the customer base knowledge and hands-on experience with the AUGMENT treatment. In 2015, the Company recognized revenue from 22 AUGMENT cycles for the full fiscal year.
Net loss for the quarter ended March 31, 2016 was $21.8 million,
$0.80) per share, as compared to net loss of $17.2 million, or ( $0.65) per share, for the same period in 2015. Net loss for the quarter ended March 31, 2016included non-cash stock-based compensation expense of $3.6 million. The increase in net loss was primarily attributable to planned higher personnel costs, and costs associated with the commercial expansion of the AUGMENT treatment in certain international IVF clinics.
Research and development expense for the quarter ended March 31,
2016 was $6.0 million, compared to $5.7 million for the same period in
2015. This increase was primarily driven by a
$1.1 millionincrease in employee compensation and related benefits driven by the hiring of additional research and development personnel; a $0.6 millionincrease in lab supplies and patient-related costs associated with our ongoing clinical study being conducted at IVI Valencia and a $0.5 millionincrease in facilities, consulting and other costs, which was partially offset by a $2.0 milliondecrease in stock-based compensation expense related to certain mark-to-market adjustments of founders' stock, which was fully expensed and vested in the first quarter of 2015 that did not recur.
Selling, general and administrative expense for the quarter
ended March 31, 2016, was $14.5 million, as compared to $11.0
million for the same period in 2015. This increase was primarily a
result of a
$2.2 millionincrease in employee compensation and related benefits driven by the hiring of additional selling, general and administrative personnel; a $1.6 millionincrease to support our international growth and a $0.6 millionincrease in facilities and other costs, which was partially offset by a $1.0 milliondecrease in stock-based compensation expense related to certain mark-to-market adjustments of Founders' stock, which was fully expensed and vested in the first quarter of 2015 that did not recur.
As of March 31, 2016, OvaScience had cash, cash equivalents, and short-term investments of $110.1 million.
This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment, OvaPrime treatment and OvaTure treatment, including statements relating to the Company’s plans to announce data and study results, plans for growth, progress towards commercialization in
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||20,478||$||43,224|
|Prepaid expenses and other current assets||2,651||3,199|
|Total current assets||112,739||129,861|
|Property and equipment, net||8,667||8,313|
|Investment in joint venture||215||-|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||7,589||7,891|
|Total current liabilities||11,807||11,243|
|Deferred rent and other non-current liabilities||1,409||520|
|Total stockholders’ equity||108,844||126,850|
|Total liabilities and stockholders’ equity||$||122,060||$||138,613|
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended
|Costs and expenses:|
|Costs of revenues||1,176||35|
|Research and development||5,955||5,747|
|Selling, general and administrative||14,454||11,046|
|Total costs and expenses||21,585||16,828|
|Loss from operations||(21,439||)||(16,813||)|
|Interest income, net||174||44|
|Other (expense) income, net||(27||)||34|
|Loss from equity method investment||(391||)||(471||)|
|Loss before income taxes||(21,683||)||(17,206||)|
|Income tax expense||75||-|
|Net loss per share—basic and diluted||$||(0.80||)||$||(0.65||)|
|Weighted average number of shares used in net loss per share—basic and diluted||27,301||26,588|
Rebecca J. Peterson, 617-420-8736