MOUNTAIN VIEW, Calif., Nov. 5, 2015 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the quarter ended September 30, 2015. The net loss for the third quarter was $5.4 million compared to $13.3 million during the same quarter in 2014. The net loss for the nine months ended September 30, 2015 and 2014 was $18.3 million and $30 million, respectively. At September 30, 2015, Alexza had consolidated cash and cash equivalents of $11.3 million.
“We continue our efforts to increase the value of ADASUVE, our pipeline, and of Alexza,” said Thomas B. King, President and CEO of Alexza Pharmaceuticals. “In the last six months, we have moved to decrease our costs, reposition our management team, secure financing and have engaged Guggenheim to explore strategic options.”
King continued, “We concluded our near term ADASUVE commercial manufacturing in August, having successfully produced more than 110,000 units in our 2015 production campaign. Following this work, we suspended our commercial manufacturing operations and expect to realize significant cost savings beginning in the fourth quarter.”
King concluded, “We recently announced our plans to reacquire the ADASUVE U.S. commercial rights from Teva. We continue to remain confident in the long-term commercial prospects for ADASUVE and over the course of the next few months, we will evaluate all of our options and pursue the strategy that we believe will allow us to maximize value for our stockholders.”
Alexza Business Updates
- In September, Grupo Ferrer Internacional, S.A. (Ferrer) and Alexza provided an ADASUVE update on commercial activities in Europe and Latin America. Key highlights included:
- ADASUVE is now available in 283 hospital settings in the EU, compared to approximately 160 hospitals one year ago, an increase of 77%.
- ADASUVE has experienced continued sustained growth in product sales. Unit sales during the first half of 2015 were more than 6 times the number of ADASUVE units sold in the first half of 2014.
- Alexza and Ferrer continue to receive strong and consistent feedback from healthcare professionals across all countries in Europe. Countries with routine use of ADASUVE include Germany, Romania, Sweden, Norway, Finland, Denmark and Spain. The rest of the EU countries, where ADASUVE is commercially available, are in the process of listing the product in the hospital formularies, and gaining initial trial and use with patients in hospitals in these countries.
- Ferrer recently met with the EU regulatory authorities to explore the potential modification of the ADASUVE label in Europe to allow the use of the product in the outpatient setting.
- In September 2015, Alexza announced that it had retained Guggenheim Securities, LLC to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions.
- In September 2015, Alexza issued a promissory note to Ferrer. The note provides that Ferrer will loan Alexza up to $5 million in two tranches: (i) the initial tranche of $3 million was received by Alexza on September 28, 2015 and (ii) Alexza has the option to borrow the second tranche of $2 million at any time on or after January 1, 2016. The note bears interest at 6% per annum and all outstanding principal and accrued interest is due and payable upon Ferrer’s demand on May 31, 2016. Alexza issued 125,000 shares of its common stock to Ferrer as additional consideration for the loan.
- In October 2015, Alexza announced its plans to reacquire the U.S. rights for ADASUVE from Teva Pharmaceuticals USA, Inc. (Teva), a subsidiary of Teva Pharmaceutical Industries Ltd., with an estimated target completion date of January 1, 2016. Alexza and Teva also plan to restructure the obligations under the outstanding note from Teva. Alexza and Teva are working on a transition agreement to continue product availability to patients and health care providers after the return of the rights to Alexza.
- In October 2015, Alexza announced two management promotions. Catherine McAuliffe was promoted to the newly created position of Vice President, Operations, and Stacy Palermini was promoted to Vice President, Finance. Ms. Palermini is also Alexza’s Corporate Secretary and Treasurer. Thomas B. King, President and CEO, was named as Alexza’s Principal Accounting Officer and Principal Financial Officer.
Alexza’s Phase 2a clinical trial of AZ-002 (Staccato alprazolam) is 50% enrolled. AZ-002 is being developed for the management of epilepsy patients with acute repetitive seizures, sometimes called cluster seizures, or ARS. The study is being conducted at three clinical sites, and two new sites are being initiated.
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