Investor Relations (IR) Questions: pSivida Corp PSDV
Click here to return to the biotech IRQ Index
Answers received: July 2013
1. When is the last time PSDV raised cash through an offering (diluted)?
This answer remains the same as it was previously. As of June 30, 2013 there has been no cash raise except for the registered direct offering of August 7, 2011 (outlined for you previously).
2. How much cash (not cash equivalents) does pSivida have?
For the quarter ending March 31, 2013, which is the most recent information we have (the company has a June 30 fiscal year so we will not have that information until early September), the company reported $7,998,000 in cash and cash equivalents and $5,699,000 in marketable securities.
3. What and approximately when is the next known catalyst?
a. The sales of Iluvien in Germany and UK – this information will come from pSivida’s partner Alimera Sciences, although sales just started late in the second quarter so I cannot tell you specifically when we will begin to see the profit split start to show up in pSivida’s reporting. Alimera Sciences has licensed Iluvien from pSivida and they are totally in charge of the marketing/sales of the product in Europe.
b. The “official” decision from NICE in terms of reimbursement approval for Iluvien in UK – we know that they a recommendation has been made to provide reimbursement of Iluvien for chronic DME patients who have already had cataract surgery.
c. October 17, 2013 is the PDUFA date for Iluvien for DME in the US. Alimera did refile with the FDA and the October 17 date was assigned. Alimera is seeking approval for Iluvien for DME for those patients who are unresponsive to other therapies (chronic patients). This is the same indication that Iluvien has been approved for in Europe. This decision is obviously important to pSivida because if Iluvien is approved in US, pSivida is entitled to a $25M milestone payment form Alimera in addition to the profit split.
d. pSivida has initiated the first of its two planned phase 3 trials for uveitis using the exact same device/drug as Iluvien (Alimera does not have rights to uveitis with Iluvien). This is the first of two planned trials that will deal with a total of 300 patients. It is possible, that should Iluvien for DME be approved by the FDA that pSivida may consider a different approval designation for the uveitis product that would require only one phase 3 trial, but there is no way to know this until we learn of the FDA decision – so for now it is two trials consisting of a total of 300 patients with a one year follow-up.
e. Other milestones would most likely deal with developments for the company’s second technology – Tethadur, which is a delivery system for proteins, peptides and antibodies. There are several evaluation agreements currently underway, whereby other companies pay pSivida to test their own molecules in the system – these evaluation agreements can lead to license agreements if successful. Unless and until a license agreement is reached, we cannot mention the companies that are evaluating the technology, but all three are looking at the area of ophthalmology. (I had mentioned this in my previous answers).
These are the current known catalysts. pSivida management is very conservative and it is possible that there could be other catalysts that are not known to me at this time.
4. What is pSivida’s quarterly cash burn? It has been running approximately $2M per quarter, however, with the start of the uveitis trials it is expected to increase (bear in mind these are very small trials, though and only the first has started recruiting). The company has not provided a different cash burn number publicly.
5. Does PSDV have an existing line of credit and if so how much can they draw against it.
The company does not have such a line of credit.
1. When is the last time PSDV raised cash through an offering (diluted)?
This answer remains the same as it was previously. As of June 30, 2013 there has been no cash raise except for the registered direct offering of August 7, 2011 (outlined for you previously).
2. How much cash (not cash equivalents) does pSivida have?
For the quarter ending March 31, 2013, which is the most recent information we have (the company has a June 30 fiscal year so we will not have that information until early September), the company reported $7,998,000 in cash and cash equivalents and $5,699,000 in marketable securities.
3. What and approximately when is the next known catalyst?
a. The sales of Iluvien in Germany and UK – this information will come from pSivida’s partner Alimera Sciences, although sales just started late in the second quarter so I cannot tell you specifically when we will begin to see the profit split start to show up in pSivida’s reporting. Alimera Sciences has licensed Iluvien from pSivida and they are totally in charge of the marketing/sales of the product in Europe.
b. The “official” decision from NICE in terms of reimbursement approval for Iluvien in UK – we know that they a recommendation has been made to provide reimbursement of Iluvien for chronic DME patients who have already had cataract surgery.
c. October 17, 2013 is the PDUFA date for Iluvien for DME in the US. Alimera did refile with the FDA and the October 17 date was assigned. Alimera is seeking approval for Iluvien for DME for those patients who are unresponsive to other therapies (chronic patients). This is the same indication that Iluvien has been approved for in Europe. This decision is obviously important to pSivida because if Iluvien is approved in US, pSivida is entitled to a $25M milestone payment form Alimera in addition to the profit split.
d. pSivida has initiated the first of its two planned phase 3 trials for uveitis using the exact same device/drug as Iluvien (Alimera does not have rights to uveitis with Iluvien). This is the first of two planned trials that will deal with a total of 300 patients. It is possible, that should Iluvien for DME be approved by the FDA that pSivida may consider a different approval designation for the uveitis product that would require only one phase 3 trial, but there is no way to know this until we learn of the FDA decision – so for now it is two trials consisting of a total of 300 patients with a one year follow-up.
e. Other milestones would most likely deal with developments for the company’s second technology – Tethadur, which is a delivery system for proteins, peptides and antibodies. There are several evaluation agreements currently underway, whereby other companies pay pSivida to test their own molecules in the system – these evaluation agreements can lead to license agreements if successful. Unless and until a license agreement is reached, we cannot mention the companies that are evaluating the technology, but all three are looking at the area of ophthalmology. (I had mentioned this in my previous answers).
These are the current known catalysts. pSivida management is very conservative and it is possible that there could be other catalysts that are not known to me at this time.
4. What is pSivida’s quarterly cash burn? It has been running approximately $2M per quarter, however, with the start of the uveitis trials it is expected to increase (bear in mind these are very small trials, though and only the first has started recruiting). The company has not provided a different cash burn number publicly.
5. Does PSDV have an existing line of credit and if so how much can they draw against it.
The company does not have such a line of credit.
Answers received January 2013
1) When is the last time PSDV raised cash through an offering (diluted)?
pSivida completed a registered direct offering of 2,494,419 common shares and 623,605 warrants (exercisable at $2.50) on August 7, 2011. The gross proceeds were $5.36 million and the offering was sold as units – one share of common stock plus one warrant to purchase 0.25 shares of common stock at a negotiated price of $2.15 per unit. The warrants are exercisable during a period commencing six months after the issue (they are exercisable then starting on February 7, 2013. I want to add however, that although on the surface it would be considered dilutive, in actually it sort of wasn’t because more than 4.32 million warrants expired last year (the last of them expiring in July). Currently there are 1.176 million warrants out with a weighted price of $3.67 – they are broken down in terms of 552,500 warrants from a financing in January 2011 that are exercisable at $5 and expire in January 2016 and the warrants from the August financing.
2) How much cash (not cash equivalents) does PSDV have? pSivida will most likely report their case position at the end of December 31, 2012 in early February. However, at September 30, 2012 the company had $17.6 million in cash including net proceeds from the above-mentioned offering of $4.7 million.
3) What and approximately when is the next known catalyst? There could be several – we are looking for:
a) start of sales of Illuvien in Germany – Q1
b) refiling with the FDA for approval of Iluvien – expected in Q1 and if accepted would start the clock toward a decision – most believe this will be a six month period, but can’t definitively state that until Alimera refiles (and as licensee, they will do the refiling, not pSivida).
c) pSivida’s own activities in connection with their phase 3 trials for uveitis – this is the exact same drug as Iluvien for DME that is licensed to Alimera, but Alimera has no rights to the product in uveitis. It is particularly interesting for pSivida because pSivida developed the first implant for uveitis, Retisert (licensed to Bausch & Lomb) which is a surgically implanted device that releases the exact same steroid as Iluvien. The FDA approved Retisert – even with significant side effects – for the treatment of uveitis – pSivida is very optimistic because the side effect profile for Iluvien from the DME trials, indicated that side effects were significantly less than those recorded with Retisert and Retisert was approved. pSivida has full reference rights to all data from the Iluvien for DME phase 3 trials and the FDA has told pSivida that they can go directly to two pivotal phase 3 trials and the FDA will require a one year follow up.
d) the company also has its glaucoma program underway with a bioerodible version of the durasert technology (the underlying technology for Iluvien and pSivida’s uveitis product). This is still in phase one-two trials and we expect some news in that area in either Q1 or 2 – this is also the program for which Pfizer has an option at the end of a full phase two to either pick up the program and take it forward (and pay pSivida a milestone of $20M and other milestones, as well as double digit royalty –and it’s not 10% or pSivida can carry the program forward on its own if it so chooses)
e) the company’s protein delivery system – this is in its early stage and the first product in this area, Tethadur, is presently under an evaluation agreement by a large global biopharmaceutical company in the ophthalmic space. Obviously there are two companies working in this area with products for ophthalmic diseases that require monthly or so injections – until this goes further we cannot identify the specific company however. In this area the company is also working on some additional efforts and we expect news in that area sometime in this quarter.
4) What is PSDV's quarterly cash burn? It has historically been $1.5M but to be conservative let’s say $1.5-$2M per quarter
5) Does PSDV have an existing line of credit and if so how much can they draw against it? The company does not have such a line of credit.