Stock Alert for AEterna Zentaris Inc. (USA)($AEZS)
AEterna Zentaris Inc. (USA) (NASDAQ: $AEZS)
AEterna Zentaris Inc. (AEZS) is a global biopharmaceutical company focused on endocrine therapy and oncology. The Company’s product pipeline encompasses compounds at all stages of development, from drug discovery through marketed products. The products of the Company include Cetrorelix, AEZS-108, Perifosine, Ozarelix, AEZS-112 and AEZS-130. On March 31, 2008, the Company completed the selling of the Company’s product, Impavido, to Paladin Labs Inc. (Paladin). On March 5, 2009, the Company entered into a development, commercialization and license agreement with sanofi-aventis for the development, registration and marketing of cetrorelix in benign prostatic hyperplasia (BPH) for the U.S. market.
Æterna Zentaris Inc. was founded in 1991 and is headquartered in Quebec City, Canada.
| Share Statistics (6-May-10) | FY
2007 |
FY
2008 |
%
Chg |
Q4 2008 | Q4 2009 | %
Chg |
||
| Symbol | AEZS | Revenue, $Mn | 42.07M | 38.48M | 8.5% | 7.24M | 40.18M | 455.0% |
| Current price | $1.38 | Gross marg. | 69.3% | 49.9% | 28.0% | 75.1% | 90.6% | 17.1% |
| 52wk Range: | $3.25-0.75 | Oper. margin | -82.6% | -162.1% | 38.5% | -225.4% | 28.6% | 112.7% |
| Avg Vol (3m): | 1.949.140 | Net margin | -89.0% | -145.7% | 63.7% | -162.4% | 46.1% | 128.4% |
| Market Cap. | 102.40M | |||||||
| Dil. Shares Outst. | 74.2M | EPS, $ | -0.61 | -1.12 | 83.6% | -0.27 | 0.30 | 211.1% |
Source: Reuters.com, SEC Filings.
Financial Summary
Revenues were $40.2 million for the fourth quarter ended December 31, 2009, compared to $7.2 million for the same quarter in 2008. The significant increase in revenues is due primarily to the Company’s having recognized the remaining unamortized portion, or approximately $30.4 million, of the upfront payment received from sanofi-aventis as part of its development and marketing agreement for cetrorelix in BPH.
Net research and development (“R&D”) expenses were $10.6 million for the quarter ended December 31, 2009, compared to $12.2 million for the same quarter in 2008. The decrease in R&D expenses primarily relates to lower costs having been incurred in connection with the Company’s Phase 3 program for cetrorelix in BPH, given the progressive completion through the end of 2009 of efficacy and safety studies associated with that compound.
Selling, general and administrative (“SG&A”) expenses were $6.2 million for the quarter ended December 31, 2009, compared to $3.0 million for the same quarter in 2008. The increase in SG&A expenses is predominantly related to the expensing of the remaining unamortized portion, or approximately $3.0 million, of the royalty paid to Tulane University in connection with the agreement entered into with, and subsequently terminated by, sanofi-aventis.
Net earnings were $12.0 million, or $0.19 per basic and diluted share, for the quarter ended December 31, 2009, compared to a net loss of $14.5 million, or $0.27 per basic and diluted share,
for the same quarter in 2008. The significant increase in net earnings is largely attributable to the significant increase in license fee revenues, combined with lower comparative R&D expenses, as discussed above, partly offset by increased SG&A expenses and depreciation and amortization charges.
Cash and cash equivalents were $38.1 million as at December 31, 2009.
CONSOLIDATED RESULTS AS AT AND FOR THE FULL YEAR ENDED DECEMBER 31, 2009
Revenues were $63.2 million for the year ended December 31, 2009, compared to $38.5 million for the year ended December 31, 2008. The increase in revenues in 2009 is almost exclusively attributable to license fee revenues related to the upfront payment received from sanofi-aventis, partly offset by lower royalty revenues having been recognized in 2009 in connection with AEZS’ agreement with Merck Serono for Cetrotide®.
R&D costs were $44.2 million for the year ended December 31, 2009, compared to $57.4 million for the year ended December 31, 2008. The decrease in R&D costs is largely attributable to a lower volume of expenses having been incurred in 2009 related to the continued advancement during the first nine months of 2009, followed by the winding down of the Company’s development activities linked to cetrorelix in BPH subsequent to its announcements that its related Phase 3 studies did not reach their primary endpoints.
SG&A expenses decreased to $16.0 million for the year ended December 31, 2009, compared to $17.3 million for the year ended December 31, 2008. The decrease is related to comparative euro-to-U.S. dollar exchange rate fluctuations and to the absence in 2009 of certain non-recurring corporate expenses due to cost-saving measures that were implemented beginning in the second quarter of 2008, despite the additional selling expenses charged during 2009 as pertaining to the royalty paid to Tulane University.
Net loss was $24.7 million, or $0.43 per share for the year ended December 31, 2009, compared to $59.8 million, or $1.12 per basic and diluted share, for the year ended December 31, 2008. The significant decrease in net loss is due to the significant year-over-year increase in license fee revenues, associated mainly with agreements for cetrorelix and ozarelix, combined with lower comparative R&D, SG&A and income tax expenses, partly offset by lower comparative sales and royalties and increased depreciation and amortization expenses and foreign exchange losses.
| Financial Strength (6-May-2010) | Company | Industry | Sector | S&P 500 |
| Quick Ratio (MRQ) | 2.31 | 5.28 | 2.56 | 0.71 |
| Current Ratio (MRQ) | 2.54 | 5.72 | 3.07 | 0.84 |
| Long-Term Debt to Equity (MRQ) | 1.55 | 20.42 | 24.12 | 124.73 |
| Total Debt to Equity (MRQ) | 2.17 | 25.03 | 30.90 | 184.89 |
Source: Reuters.com, SEC Filings.
Analyst Consensus
| Buy | Outperform | Hold | Underperform | Sell | No Opinion |
This is the consensus forecast amongst six polled investment analysts. Against the AEterna Zentaris Inc company.
| Analyst Detail | Buy | Outperform | Hold | Underperform | Sell | No Opinion |
| Latest | 2 | 1 | 2 | 1 | 0 | 2 |
| 4 weeks ago | 2 | 1 | 2 | 1 | 0 | 2 |
| 2 months ago | 2 | 1 | 2 | 1 | 0 | 2 |
| 3 months ago | 2 | 1 | 2 | 1 | 0 | 2 |
| Last year | 3 | 3 | 1 | 0 | 0 | 1 |
Source: www.ft.com
Consensus Estimates Analysis
| # of Estimates | Mean | High | Low | 1 Year Ago | |
| SALES (in millions) | |||||
| Quarter Ending Jun-10 | 2 | 6.43 | 7.05 | 5.81 | 10.50 |
| Quarter Ending Sep-10 | 2 | 6.51 | 7.16 | 5.86 | 11.00 |
| Year Ending Dec-10 | 6 | 26.55 | 31.70 | 22.40 | 37.91 |
| Year Ending Dec-11 | 4 | 25.12 | 27.36 | 22.57 | 38.57 |
| EARNINGS (per share) | |||||
| Quarter Ending Jun-10 | 2 | -0.09 | -0.08 | -0.09 | -0.09 |
| Quarter Ending Sep-10 | 2 | -0.09 | -0.08 | -0.09 | -0.08 |
| Year Ending Dec-10 | 6 | -0.44 | -0.34 | -0.60 | -0.40 |
| Year Ending Dec-11 | 4 | -0.33 | -0.20 | -0.45 | -0.17 |
Source: http://www.reuters.com/finance/stocks/financialHighlights?symbol=AEZS.W
Investment Highlights
AEZS recently announced that it has received from the U.S. Food and Drug Administration (FDA) orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.
2009 Highlights
Perifosine
- Updated positive Phase 2 efficacy and safety data as well as new survival data for perifosine in combination therapy for relapsed/refractory multiple myeloma, were presented at the American Society of Hematology’s (“ASH”) annual meeting. Results showed that the overall response rate was 41% and median overall survival was reported at 25 months for all evaluable patients. The combination therapy maintained an acceptable safety profile and no unexpected adverse events were reported.
- Positive Phase 2 data on perifosine in advanced metastatic colon cancer and in advanced renal cell carcinoma were presented at the American Society of Clinical Oncology’s (“ASCO”) annual meeting. The data demonstrated perifosine’s anti-cancer activity and efficacy both as a single agent and in combination therapy. Data at ASCO and ASH meetings were generated by the Company’s North American partner, Keryx Biopharmaceuticals (“Keryx”).
- A Phase 3 registration trial with perifosine in relapsed/refractory multiple myeloma was initiated under a Special Protocol Assessment (“SPA”). Perifosine was also granted Orphan Drug and Fast Track designations by the Food and Drug Administration (“FDA”) in this same indication. The trial is being conducted by Keryx.
AEZS-108
- Positive Phase 2 preliminary results with AEZS 108 in platinum-resistant and taxane-pretreated ovarian cancer were disclosed, which showed that the study met its primary efficacy endpoint of five or more responders in 41 evaluable patients.
- Positive Phase 2 preliminary results with AEZS-108 in advanced or recurrent endometrial cancer were disclosed. The study met its pre-defined primary efficacy endpoint of five or more responder patients. The trial in endometrial and ovarian cancer was conducted in collaboration with the German oncology study cooperative group, Arbeitsgemeinschaft Gynackologisehe Onkologie (“AGO”). Data for both indications were presented at the American Association for Cancer Research’s (“AACR”) annual meeting.
AEZS-112
- Phase 1 results with AEZS 112 in advanced solid tumors or lymphoma were disclosed, showing prolonged courses of stable disease, excellent tolerability and potential for long-term use as a combination treatment for cancer.
AEZS-130
- A Poster was presented at the Endocrine Society’s (“ENDO”) annual meeting, on AEZS 130 (SolorelTM), reporting the first clinical data relating to its use as a simple oral diagnostic test for adult Growth Hormone Deficiency (GHD).
Cetrorelix
- A licensing agreement with sanofi-aventis U.S. (“sanofi-aventis”) for the development, registration and marketing of cetrorelix in benign prostatic hyperplasia (“BPH”) for the U.S. market was signed. The agreement provided Æterna Zentaris with a $30 million gross upfront payment.
- Results of two Phase 3 efficacy studies with cetrorelix in BPH, which did not achieve their primary endpoint, were disclosed.
- The Company’s licensing agreement with sanofi-aventis for cetrorelix in BPH, subsequent to the aforementioned Phase 3 results, was terminated.
Corporate Developments
- The Company completed two registered direct offerings of common shares and warrants to certain U.S. institutional investors, for combined gross proceeds of $15.5 million.
Subsequent to Year-End
- A statistically significant benefit in survival from updated results of a Phase 2 study of perifosine in advanced metastatic colon cancer was reported by Keryx.
- A publication in the February 2010 issue of the Journal of Clinical Cancer Research reported positive Phase 2 results for perifosine as a single agent for the treatment of advanced Waldenstrom’s macroglobulinemia.
- The FDA granted an SPA for the Phase 3 trial of perifosine in combination therapy for refractory metastatic colorectal cancer. The trial is to be conducted by Keryx.
- The Committee for Orphan Medicinal Products of the European Medicines Agency issued a positive opinion to Æterna Zentaris for orphan medicinal product designation for perifosine in multiple myeloma.
Source: http://www.aezsinc.com/
Technical Analysis
Source: http://stockcharts.com
AEZS is trading above its 50-day moving average. This is considered to be the sign of a bullish trend. There is added weight to this indication because the moving average is rising and suggests that there has been buying interest in this stock.
AEZS’s recent volatility has been greater than normal. This is evidenced by the increased distance between the upper and lower Bollinger Bands. These bands measure volatility using standard deviation and a large width is due to high volatility. Additionally, AEZS is trading within its Bollinger Bands. This is a normal condition and suggests that the stock is neither overbought nor oversold relative to the recent price action.
The MACD for AEZS currently indicates a strong bullish signal for two reasons. First, the MACD is above the signal line, a 9-day moving average. Second, the MACD is above 0, which implies that the underlying moving averages are trending higher.
Comparative Analysis
| Company Name | Ticker | Price per | Mrkt. Cap. | P/E | P/S | ||
| May-6-2010 | symbol | Share, $ | $ Mn | 2009 | 2010 | 2009 | 2010 |
| Helix Biopharma Corp. | HBP | 2.39 | 142.92M | n/a | n/a | 36.59 | n/a |
| Protox Therapeutics Inc. | PRX | 0.60 | 57.92M | n/a | n/a | n/a | n/a |
| Spectrum Pharmaceuticals Inc. | SPPI | 4.81 | 236.51M | n/a | n/a | 6.69 | n/a |
| Drug Manufacturers Median | 145.78M | 14.30 | n/a | 21.64 | n/a | ||
| AEterna Zentaris Inc. | AEZS | 1.38 | 102.40M | n/a | n/a | 1.41 | n/a |
Source: Thomson Financial
Insider Trading Activity
| NET SHARES PURCHASE ACTIVITY
Inside Purchases – Last 6 Months |
||
| Shares | Transaction | |
| Purchases | n/a | n/a |
| Sales | n/a | n/a |
| Net Shares Purchased (Sold) | n/a | n/a |
| Total Insider Shares Held | n/a | n/a |
| % Net Shares Purchased (Sold) | n/a | n/a |
| Net Institutional Purchases — Prior Qtr to Latest Qtr | |
| Shares | |
| Net Shares Purchased (Sold) | n/a |
| % Change in Institutional Shares Held | n/a |
Source: Yahoo Finance
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